DEPUY SYNTHES PRODUCTS LLC ADAPTOR FOR RADIOLUCENT DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.031 |
Device Problems
Device Inoperable (1663); Noise, Audible (3273)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/14/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: multi-humeral nail device, radiolucent drive device, quick coupling device and small battery drive device.(b)(6).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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This is report 2 of 4 for the same event.It was reported from (b)(6) that during an open reduction internal fixation (orif) surgical procedure for a humerus diaphysis fracture using the multi-humeral nail long (mhn long) device, it was observed that the small battery drive device stopped working while drilling the first distal hole.According to the report, the event occurred after a proximal hole was fixed.It was reported that the small battery drive device was in use with a radiolucent drive device, adaptor device and a quick coupling device.It was further reported that the small battery drive device kept running idle with a scratching sound.It was reported that the surgeon reassembled the unit again and tried drilling but could not complete the drilling as the same issue occurred.As a result, the surgeon created the prepared hole with a gimlet and then drilled by hand.It was reported that the same event occurred at the second hole but the surgeon completed drilling using the same manual way.It was reported that the surgeon took time to change the battery and tried the same way at the third hole.It was reported that although the small battery drive device was about to stop, the surgeon managed to complete the drilling.It was reported that there was a 30 minute delay in the surgical procedure and the surgery was completed successfully using the same device.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Manufacturer Narrative
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The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the device passed all manufacturing specifications.Therefore, the reported condition was not duplicated and confirmed.An assignable root cause was not determined.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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