OBERDORF SYNTHES PRODUKTIONS GMBH HCS Ø3 SELF-DRILL CANN L22/8 TAN GOLD; SCREW,FIXATION,BONE
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Catalog Number 04.226.122S |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Code Available (3191)
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Event Date 10/01/2019 |
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.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.(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation for distal humerus fracture, during the surgery the surgeon could not insert the headless compression screw completely.It was scheduled that the bone was pressed with the screw and fixed with a plate.The screw head was stripped when trying to bury it after inserting the screw shaft.The screw was removed and the bone was fixed with only the plate.The surgery was delayed by less than 30 minutes.The surgeon stated that the drill bit for the cortical bone is needed to insert the screw completely.No further information is available.Concomitant devices: unknown drill bits: trauma (part # unknown, lot # unknown, quantity # 1), unknown plates (part # unknown, lot # unknown, quantity# 1).This report is for one (1) hcs ø3 self-drill cann l22/8 tan gold.This is report 1 of 1 for (b)(4).
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