SYNTHES BETTLACH PFNA BLADE PERF L100 TAN; APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT
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Catalog Number 04.027.035S |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Patient information is not available for reporting.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing location: (b)(4).Manufacturing date: 29.Aug.2016 expiry date: 01.Aug.2026.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 (b)(4) reports an event in (b)(6) as follows: it is reported the proximal femoral nail antirotate (pfna) blade would not lock during an unknown procedure on unknown date.No surgical delay was reported.Concomitant devices reported: pfna nail (part number unknown, lot number unknown, quantity 1) this report is for one (1) pfna blade this is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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