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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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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It was reported that during a procedure on (b)(6) 2022, two guide rod rulers from the ans set and flexible reamers were combined to inaccurately measure tibial nail length.Measuring device 351.717 was combined with elongation tube 03.045.036.This event added 10 minutes to the surgery to remove the incorrect nail and replace.The procedure was completed successfully, and there was no consequence to the patient.No further information is available.This report involves one tube f/direct measuring device.This is report 1 of 1 for (b)(4).
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