DEPUY SYNTHES POWER TOOLS OSCILL-SAW-ATTACHM F/532.001 532.010 532; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
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Catalog Number 532.021 |
Device Problems
Partial Blockage (1065); Sticking (1597); 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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Additional narrative: (b)(6).The actual device was returned for evaluation.Reliability engineering evaluated the device and observed that the mechanics swing fork and saw attachment were blocked.It was further reported that the mechanics were seized, jammed and heavy moving.Therefore, the reported condition was confirmed.The assignable root cause was determined to be wear from normal use and servicing.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 saw attachment device was not oscillating.During an in-house engineering evaluation, it was observed that the mechanics swing fork and saw attachment were blocked.It was further reported that the mechanics were seized, jammed and heavy moving.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 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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