Catalog Number 400.834S |
Device Problem
Break (1069)
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Patient Problem
Injury (2348)
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Event Date 05/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history lot: part: 400.834s, lot: 3l17502, manufacturing site: (b)(4).Release to warehouse date: 29 january 2019, expiry date: 01 january 2029.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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) 2019, during the operation of superficial artery-middle cerebral artery bypass graft, the surgeon drilled the bone screw but it did not screw into the skull.The head of screw was broken and the skull was damaged.All the broken pieces were retrieved from the patient.The screw was replaced with a new one to complete the surgery.Concomitant device reported: unk- powered drivers / handpieces: trauma ( part # unknown, lot # unknown, quantity # 1), unk - screw drivers: shafts (part # unknown, lot # unknown, quantity # 1).This report is for one (1) ti low profile neuro screw self-drilling 4 mm.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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