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Device Problem
Break (1069)
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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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If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.This report is for an unknown nails: tfna/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Synthes sales rep.(b)(6).(b)(4): the complaint indicated that the nail broke post-op requiring additional surgical intervention.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.
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Event Description
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It was reported that on an unknown date, the patient underwent a removal of a trochanteric fixation nail advanced (tfna).It was seen in an x-ray that the tfna short nail with fenestrated helical blade was broken at the helical blade nail junction.Implanted devices including the locking screw were successfully removed with no surgical delay.Revision procedure done was total hip replacement.Patient status is unknown.Concomitant device reported: unknown locking screw (part#: unknown, lot #: unknown, quantity 1) this complaint involves one (1) devices.This report is 1 of 1 for (b)(4).
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Event Description
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Further it was reported that patient underwent hardware removal procedure on (b)(6) 2018.Concomitant device reported: 5.0mm locking screw (part# unknown, lot # unknown, quantity 1), tfna helical blade ( part # unknown, lot # unknown, quantity 1).
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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.Additional narrative: event: added additional event information and updated concomitant devices.Concomitant medical products.Explant date.Corrected data: device name; initial reporter professional; labeled for single use.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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