SYNTHES GMBH 2.4MM VA-LCP VOLAR RIM DISTAL RAD PL/6H HD/5H SHFT/RT-STER; PLATE, FIXATION, BONE
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Catalog Number 02.115.750S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Rupture (2208); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j & j sales consultant.(b)(4).A device history record (dhr) review was conducted: part: 02.115.750s, lot: 3l08424, manufacturing site: (b)(4), release to warehouse date: 05.Feb.2019, expiry date: 01.Jan.2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.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 synthes reports an event in (b)(6) as follows: it was reported that there was a postoperative rupture of fpl tendon.Rupture of flexor policis longus due to open reduction internal fixation (orif).There is no further information reported.Concomitant devices reported: va locking screw stardrive® ø 2.4 mm (part # 02.210.112ts, lot # unknown, quantity 5).This report is for one (1) 2.4mm va-lcp volar rim distal rad pl/6h hd/5h shft/rt-ster.This is report 1 of 6 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.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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