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Catalog Number UNK - NAILS: FEMORAL |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).This report is for (1) unknown, nails: femoral/part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Complainant device/part received.Initial reporter is j&j company representative the investigation could not be completed; no conclusion could be drawn.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) 2021, the driving cap/threaded was broken.While the surgeon was performing a femoral recon nail he had over rimmed by 2mm to put in a at 10 mm x 400 mm left femoral recon nail.When the surgeon inserted the nail he started to loosen the insertion handle and tighten the driving cap with the ratchet wrench and resume impacting the nail with the nail inserted about 300mm the driving cap broke off.There was a twelve to fifteen minutes surgical delay.The procedure outcome was unknown.There was no negative harm to the patient.Concomitant devices reported: ratchet wrench (part# 321.20, lot# unknown, quantity 1), unknown reamer (part# unknown, lot# unknown, quantity 1).This complaint involves (3) devices.This report is for (1) unk - nails: femoral.This report is 3 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, 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 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.D9: complainant part is not expected to be returned for manufacturer review/investigation.
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Search Alerts/Recalls
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