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Device Problem
Migration (4003)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Date 02/08/2022 |
Event Type
Injury
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Event Description
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Device report from depuy synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent surgery with proximal femoral nail antirotation (pfna) implants.After surgery, on (b)(6) 2022, cut-out was found.On (b)(6) 2022, pfna implants were removed and the bha was performed in the revision surgery.The revision surgery was completed successfully with no surgical delay.No further information is available.This report is for unknown pfna ii end cap.This is report 1 of 4 for complaint (b)(4).
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Manufacturer Narrative
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Additional narrative: 510k: this report is for an unknown pfna ii end cap/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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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Search Alerts/Recalls
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