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Device Problem
Unintended Movement (3026)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Patient information not available for reporting.Date of device cut out is not known.The 510k: this report is for an unknown tfna helical blade/unknown lot.Part and lot numbers are unknown; udi number is unknown.Date of implant is not known.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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 patient was implanted with a trochanteric fixation nail advanced (tfna) nail, tfna helical blade, and tfna screw on unknown date.On unknown date, patient suffered a fall which may have resulted in the tfna helical blade cut out.Patient was returned to surgery on (b)(6) 2018 for hardware removal.It is not known if patient was revised to additional hardware.Concomitant devices reported: 11mm 130 degree titanium cannulated tfna nail 235mm-right ((b)(4), lot h491637, quantity 1), tfna screw 100mm ((b)(4), lot number unknown, quantity 1).This report is for one (1) unknown tfna helical blade.This is report 1 of 1 for (b)(4).
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Event Description
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The initial complaint was reviewed and found not reportable.This complaint was confirmed to be a duplicate of (b)(4) (mfr number 2939274-2018-52519).All complaint related activities will be captured there.
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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.The initial complaint was reviewed and found not reportable.This complaint was confirmed to be a duplicate of (b)(4) (mfr number 2939274-2018-52519).All complaint related activities will be captured there.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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