Device report from synthes reports an event in the united kingdom as follows: it was reported that during surgery on (b)(6) 2023, when the surgeon tried to pull the ria out from the canal, it was noticed that the reamer head had come detached.This was successfully removed using the olive tip wire.However, four small metal splinters were present in the bone canal on the x-ray.They were successfully removed using suction, and a new reamer head was used to complete the procedure.No other medical intervention was required.Upon inspection, the spikes where the reamer head attaches to the metal drive shaft had become broken.This report is for a 13.0mm reamer head for ria 2 sterile.This is report 1 of 1 for (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.H10 additional narrative: d2b: additional device product codes: hrx.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.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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