SYNTHES USA 1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 13MM; PLATE, FIXATION, BONE
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Catalog Number 02.130.013 |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 09/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).(b)(4).Not implanted or explanted, device broke intra-operatively and shaft remains in patient's body.Device is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.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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It was reported while using a screwdriver to place a 1.3mm cortex screw during surgery on (b)(6) 2016, the head of the screw broke upon final tightening.The surgeon elected to leave the shaft of the screw in the patient.The head of the screw was easily identified and removed.There was no surgical time delay and the procedure was completed successfully.Patient outcome following surgery was reported as stable.This complaint involves 1 device.Concomitant device reported: screwdriver (part# unknown, lot# unknown, quantity 1) this report is 1 of 1 for (b)(4).
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