DEPUY SYNTHES PRODUCTS LLC SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.001 |
Device Problems
Device Stops Intermittently (1599); Mechanical Jam (2983)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the trigger was blocked, jammed and moving heavily.Therefore, the reported condition was confirmed.However, the assignable root cause could not be determined.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Event Description
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This is report 1 of 2 for the same event.It was reported from (b)(6) that that two small battery drive device would sometimes work and sometimes would not work.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in a surgical procedure or if a spare device was available.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.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 evaluation update: further investigation determined that the assignable root cause was determined to be due to premature wear.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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