SYNTHES OBERDORF SMALL BATTERY DRIVE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.001 |
Device Problems
Partial Blockage (1065); Physical Resistance (2578); Mechanical Jam (2983)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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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 coupling power supply was blocked, seized, jammed and was moving heavy.It was further determined that the insertion of the battery was rough.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If information is obtained that was not available, 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 the small battery drive device had an unspecified defect.During in-house engineering evaluation, it was observed that the coupling power supply was blocked, seized, jammed and was moving heavy.It was further determined that the insertion of the battery device was rough.It was not reported if the device was used in surgery.It was not reported if there were any delays in a surgical procedure or if a spare device was available.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown.All available information has been disclosed.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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