DEPUY SYNTHES POWER TOOLS COLIBRI II. SMALL BATTERY DRIVE DEVICE II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.101 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 from (b)(6) that during an unspecified surgical procedure, it was discovered that the small battery drive device did not work all the time.It was reported that the event occurred during use on a patient.It was not reported if there were any delays in the surgical procedure.It was reported that the surgery was completed using the same device.There was patient involvement reported.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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The actual device was returned for evaluation.During repair, it was determined that the reported condition was confirmed.It was determined that the coupling tool side was jammed and was moving heavy.It was further determined that the nose seals, bearings and nose casing were worn.It was determined that the device operated intermittently.It was further determined that the device failed pretest for check the attachment coupling and check power with test bench, mln.67.5 to 110 w.The assignable root cause was determined to be due to improper handling.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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