Model Number 279734000N |
Device Problem
Break (1069)
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Patient Problems
No Consequences Or Impact To Patient (2199); Not Applicable (3189)
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Event Date 03/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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, during insertion of implant, the navigation driver tip broke off in implant.Implant was removed and replaced.Patient had sclerotic bone.One minute delay reported.
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Manufacturer Narrative
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Product complaint # (b)(4).Visual examination at the macroscopic level revealed that the fracture was located at the driver¿s distal tip.The second half of the driver was not returned for evaluation.Device was then sent for fracture analysis.The fracture analysis report reveals plastic deformation at the hexlobes and torsional shear markings following a circular pattern.This suggests that the fractured tip underwent a quasi-static overload torsional shear failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the poly driver¿s distal tip fracturing cannot be positively determined.However, the fracture analysis report suggests that the fractured tip underwent a quasi-static overload torsional shear failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.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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