OBERDORF SYNTHES PRODUKTIONS GMBH TFNA HELICAL BLADE 90MM STERILE; ROD,FIXATION,INTRAMEDULLARY
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Catalog Number 04.038.290S |
Device Problem
Migration (4003)
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Patient Problems
Failure of Implant (1924); 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.(b)(4).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 history lot: manufacturing location: (b)(4) / packaged, sterilized and released by: (b)(4).Release to warehouse date: june 8, 2020.Expiration date: may 1, 2030.Part number: 04.038.290s, tfna helical blade 90mm -sterile lot number: 57p7431 (sterile) note: helical blade was manufactured by (b)(4); lot number 57p0989.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) lmd rev ac was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn (b)(4) supplied by (b)(4) was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history review this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture 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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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) 2020, the patient underwent the surgery with the blade in question.On an unknown date, the surgeon confirmed that the cut-out occurred, and the blade was inserted more proximal position than the proper position.On october 16, the patient underwent the revision surgery and in the revision the blade was removed and re-inserted at the proper position.No further information is available.Concomitant device reported: tfna nail (part# 04.037.242s, lot# 46p1538, quantity 1), locking screw (part# 04.005.526s, lot# 7l05589, quantity 1), unknown end cap (part# unknown, lot# unknown, quantity 1).This report is for one (1) tfna helical blade 90mm sterile.This is report 1 of 1 for (b)(4).
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Search Alerts/Recalls
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