WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: FEMORAL; ROD,FIXATION,INTRAMEDULLARY
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Catalog Number UNK - NAILS: FEMORAL |
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 03/10/2022 |
Event Type
Injury
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Event Description
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Device report from synthes reports an event in the usa as follows: it was reported on (b)(6) 2022, there was an unknown trochanteric femoral nail breakage.The original surgery was done on (b)(6) 2021.Procedure and patient outcome were unknown.Concomitant device reported: unk - screw (part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device unk - nails: femoral.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Product complaint (b)(4).Additional narrative: 510k: this report is for an unknown nails: femoral/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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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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.E1: initial reporter facility name and address.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventive 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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