OBERDORF SYNTHES PRODUKTIONS GMBH 12MM/130 DEG TI CANN TFNA 360MM/LEFT-STERILE; ROD,FIXATION,INTRAMEDULLARY
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Catalog Number 04.037.257S |
Device Problem
Break (1069)
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Patient Problems
Failure of Implant (1924); Injury (2348)
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Event Date 11/14/2017 |
Event Type
Injury
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Manufacturer Narrative
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Patient¿s identifier, weight are unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter phone number is not provided for reporting.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 europe reports an event in (b)(6) as follows: it was reported that the patient had a hip surgery on (b)(6) 2016.Post-operatively the distal locking screw broke on (b)(6) 2017.No revision surgery was performed at that time.There was postoperative varus collapse of proximal femur and associated proximal nail breakage occurred on (b)(6) 2017.The patient had a hip replacement surgery on (b)(6) 2017.Patient is recovering.This report addresses post-operative nail breakage and the postoperative breakage of distal locking screw has been reported under linked complaint (b)(4).Concomitant devices reported: tfna helical blade (part # 04.038.390s, lot # 7882706, quantity 1), locking screw (part # 04.005.534, lot # l014460, quantity 1).This report is for one (1) 12mm/130 deg ti cann tfna 360mm/left-sterile.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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A device history record review was performed for the subject device: manufacturing location: monument.Manufacturing date: 13-jan-2016, expiration date: 31-dec-2025.Part #: 04.037.257s, lot#: 9969760 (sterile) - 12mm/130 deg ti cann tfna 360mm/left- sterile.Quantity 4.Inspection sheet for in-process/inspect dimensional/final and inspection sheet - tfna assembly inspection met inspection acceptance criteria.Component parts reviewed: 04.037.942.2 - lock prong 130 degree, tfna bp-55 lot - 9726276, 04.037.912.4 - wave spring, shim ended bp-55 lot - 9850945 , 04.037.912.3 - tfna lock drive bp-58 lot - 9946966, 21127 - raw material lot bp-80 lot ¿ 7552486.Raw material received from metalwerks pmd, inc.Certificate of analysis received from metalwerks for titanium meet specification.Raw material receiving/putaway checklist meet requirements.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.Scn no:ethicon (abq), ¿sterility documentation was reviewed and determined to be conforming.¿ 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.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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Upon review of the received x-ray pictures, it can be confirmed that the nail was broken post-operative as complained.Product was not returned; therefore no further investigation is possible.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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