DEPUY SYNTHES PRODUCTS LLC BATTERY REAMER/DRILL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.605 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi: (b)(4).This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the control unit was defective and not functioning properly.It was further determined that the device failed pretest for change 10 times from forward to reverse at full speed and check the off/forward/reverse mode.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Event Description
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It was reported from (b)(6) that the battery reamer device stopped running during use.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 the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported, however it was reported that the event occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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