Correspondence Address:
Dr. Ganesh Singh Dharmshaktu
Department of Orthopaedics, Government Medical College, Haldwani - 263 139, Uttarakhand
India

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The intraoperative failure of instrument, used for internal fixation of a fracture followed by application of appropriate implant, is a rare but potential complication in orthopedic surgery.[1] One case related to breakage of conical bolt, used to fasten the nail into the jig assembly before insertion, near proximal knobbed part was reported by us in this journal before.[2] Substandard implants, prolonged use, and rough handling or hammering are common reasons for increasing the risk. We witnessed another case of conical bolt breakage as an incidental intraoperative finding during second surgery and wished to shortly describe it for novelty and educational purpose.

A 40-year-old male patient was treated for his left-side femur shaft fracture with closed anterograde intramedullary interlocking nail 2 years back. The procedure was uneventful and the fracture united in that period with excellent functional outcome and consolidated radiological union. He again visited us this time for removal of the nail and was prepared for the surgery after informed consent. The nail removal was planned in a lateral position with the hip flexed to 90° so that the entry site is better accessed. All distal and one of the proximal screws were removed while the other one was partially kept engaged to assist good fastening of removal apparatus. The entry site was exposed and area near trochanter was cleared till the proximal nail entry and hollow of nail was visible. At this time, we noticed the hollow of the nail with a metallic object within [Figure 1]a. On careful assessment, it was clear that part of the jig that attaches with the nail during insertion had broken and left in situ during primary surgery. The attempt to unscrew and loosen the broken part was done, and on multiple attempts, we could catch hold of the piece with artery forceps and carefully removed it off the nail [Figure 1]b. The nail was then easily removed, and wounds were closed and healed well later [Figure 1]c. Follow-up was uneventful, and after period of guarded amb ulation, the patient resumed full activities of daily living.{Figure 1}

Among various instruments that may inadvertently break during surgery, failure of proximal jig assembly used for intramedullary nailing of long bones is rare.[3] The breakage of jig bolt at the distal end near the screw threads is a potential complication and may occur in a similar fashion as it occurs with bone screws. It might have broken due to hammering, prolonged overuse, or due to prolongation of preexisting microcrack leading to fatigue failure. The removal of jig following insertion of nail was done, and the breakage was not noticed by a surgeon or assisting staff. Later, implant vendor also might have overlooked or replaced the jig as routine usual process. This case highlights the importance of inspection of every object that goes inside after its use to check that the object is out in toto. The assisting operative room personnel should also double-check it during cleaning and report it in requisite register. The implant vendors should also be instructed to provide information of missing hardware they receive. There is an initiative to report complication and adverse events related to medical devices under the Materiovigilance Program of India (MvPI) launched way back in the year 2015.[4] We have come to know about it a few days back online when cranial perforators and drill bits were notified by them.[5] It is advisable to urge all fellow orthopedic surgeons to report any instrument, medical device, or implant failures to these agencies in future. The knowledge of materiovigilance and its collection, however, have not been known or publicized to many doctors in contrast to its pharmacovigilance counterpart. It would be advisable to keep records of each such complication so that comprehensive overview can be gained out of collective efforts. Similarly, it is expected to MvPI to better advertise and inform about itself through all channels of communication and have an outreach program so that many can contribute to its success.

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The authors certify that they have obtained all appropriate patient consent forms. In the form the patient (s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initial s will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.

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Conflicts of interest

There are no conflicts of interest.

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