SYNTHES GMBH 9MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Model Number 04.037.915S |
Device Problem
Break (1069)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/23/2022 |
Event Type
Injury
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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.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: initial reporter is a synthes employee.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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Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent a surgery for trochanteric fracture of the femur.After surgery, on (b)(6) 2022, it was found that the nail was broken at the distal end where a locking screw was inserted, and that fracture occurred as well.On (b)(6) 2022, a revision surgery to replace the nail with a longer one was performed.No further information is available.This report is for a 9mm/125 deg ti cann tfna 235mm/left - sterile.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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