SYNTHES OBERDORF OSCILLATING-SAW-ATTACHM W/QUICK-COUPL; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
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Catalog Number 511.801 |
Device Problems
Partial Blockage (1065); Device Inoperable (1663); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the gear was seized, jammed, blocked and heavy moving.Therefore, the reported condition was confirmed.The assignable root cause was determined to be improper maintenance and cleaning of the device.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 the locking mechanics for the cutting tool on the oscillating saw attachment device was not functioning.During an in-house engineering evaluation, it was observed that the gear was seized, jammed, blocked and heavy moving.It was not reported if the device was used in surgery, or if there was patient involvement reported.It was not reported if there were any delays in a scheduled 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 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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