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Model Number 03.037.017 |
Device Problems
Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2023 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2023, after inserting the helical blade, the surgeon was unable to disengage the guide sleeve from the aiming arm.Surgeon removed the entire 125 aiming arm with the instruments attached, the nurse opened a 2nd set of instruments that were available to complete the distal locking portion of this procedure.There was no negative patient impact as another set of instruments was readily available to complete the procedure.The instruments were unable to be separated from one another, and upon inspection the threads on the guide sleeve seemed to be stripped.There was no surgical delay.Procedure was completed successfully.This complaint involves two (2) devices.This report is for one (1) blade/screw guide sleeve.This is report 2 of 2 for complaint (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).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.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The initial reporter is a j&j sales representative.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 history lot: part# 03.037.017.Lot # 9661610.Manufacturing site: werk bettlach.Supplier: na.Release to warehouse date:23 sep 2015.Expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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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Search Alerts/Recalls
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