OBERDORF SYNTHES PRODUKTIONS GMBH 11MM/130 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY
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Model Number 04.037.161S |
Device Problem
Use of Device Problem (1670)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Without a lot number the device history records review could not be completed.Product was not returned.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 colombia as follows: it was reported that on (b)(6) 2019, when performing tfna nail surgery the surgeon made a tac measurement and wanted to replace a 415 nail with a nail of length 400.He started surgery and a nail 11 was used which, upon impact, they realized it was too long.They decided to cut the distal end and reinsert it again.The surgery was finished without any other consequence and the surgeon was satisfied with the result.This report is for one (1) 11 mm/130 deg ti cann tfna 400 mm/left - sterile.This is report 1 of 1 for (b)(4).
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