Catalog Number 352.040 |
Device Problems
Device-Device Incompatibility (2919); Material Deformation (2976); Material Twisted/Bent (2981); Illegible Information (4050)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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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Event Description
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It was reported that on (b)(6) 2023, while inspecting the instruments after going through the decontamination process, it was noticed that several instruments were damaged.The handle with quick coupling, small was worn.The plastic on the handle was cracked.The drive adaptor qc for 5.0 schanz screws is a quick connect for shanz pins.Where the quick connect goes into the drill, it was worn and unable to go into the drill.The 5.0mm flexible shaft was worn.The tip of the reamer shaft has prongs on it, and the prongs were bent and unable to hold the reamer head in place.Another 5.0mm flexible shaft was damaged.The 5.0mm flexible shaft 620mm was worn.It was a long rear shaft, and the tip of the reamers shaft has prongs on it, and the prongs were bent and unable to hold the reamer head in place.It is unknown when the damage occurred to these items.There was no patient involvement.The lot numbers on the devices were worn and not legible.This report involves one 5.0mm flexible shaft.This is report 1 of 4 for (b)(4).
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Manufacturer Narrative
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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.H3, h4, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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 review (dhr): product code : 352.040, lot number# 4006213, the lot # 4006213 does not exist in the system.Dhr review cannot be completed.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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