DEPUY SYNTHES PRODUCTS LLC ME1000 BROACH-ADAPTER-ANTERIOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 1010-01-102 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.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 that during service and repair pre-testing, it was discovered that the cloverleaf fitting of the broach-adapter-anterior device was dented and did not fit into the locking collar of the impactor device.It was further reported that the device failed the visual assessment.The event was not related to surgery.There was no patient involvement.There were no injuries or medical intervention associated with this event.The exact date of the event was unknown.However, it was reported that the event occurred (b)(6) in 2018.The actual month was not specified.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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Device history record review: a device history review was performed, and no non-conformances were detected related to the reported condition.Device evaluation: the actual device was returned for evaluation.Reliability engineering evaluated the device and the reported condition was confirmed.A visual and functional assessment was performed on the device which found that the cloverleaf fitting was dented.During investigation, it was determined that the adapter was not used per manufacture¿s instruction manual.Thus, when properly installed the impact energy is not transmitted through the tip of the adapter where the fitting is dented.The assignable root cause was determined to be due to improper use.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Search Alerts/Recalls
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