SYNTHES GMBH 11MM TI CANNULATED RETROGRADE FEMORAL NAIL-EX/260MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 04.013.532 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/12/2021 |
Event Type
Injury
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Manufacturer Narrative
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Patient identifier: (b)(6).Additional device product codes: hwc.Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.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.(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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient's rafn nail with 2 screws was removed.The patient was operated on for 24 hours because the nail was short.The surgeon placed an implant that was too short for fracture reduction.Another operation was performed for reduction with osteosynthesis material.This report involves one (1) 11mm ti cannulated retrograde femoral nail-ex/260mm.This is report 1 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.Part #: 04.013.532.Lot #: h409705.Manufacturing site: (b)(4).Supplier: (b)(4).Release to warehouse date: august 18, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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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