It was reported that on (b)(6) 2023, a screw driver handle would not connect to the drive shafts.Another handle was used instead.A screw was put in that was too long.It was noticed that the depth gauge was measuring inaccurate, and ultimately the tip of the depth gauge had been broken off at some point likely not during this surgery but uncertain.The surgeons used a different depth gauge to complete the surgery.There was no adverse events occurred.During this surgery, the surgeon placed cement and an ex fix and will bring back to patient to remove the ex fix and perform an orif of a thumb in the future.There was 5 min surgical delay.Procedure was completed successfully.There was no patient consequences.Concomitant device reported: unk - biomaterial - cement: trauma(part# unknown; lot# unknown; quantity: unknown).Unk - ex-fix other(part# unknown; lot# unknown; quantity: unknown).This report is for one (1) handle with mini quick coupling.This is report 1 of 2 for complaint (b)(4).
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer.Review/investigation.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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