SYNTHES BETTLACH MINI AIR DRILL; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESSORIES AND ATTACHMENT
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Catalog Number 512.100 |
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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(b)(6).The actual device was returned for evaluation with an unspecified malfunction.Reliability engineering evaluated the device and observed that the trigger/slider was blocked, jammed and heavy moving.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 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 mini air drill device had an unspecified malfunction.During in-house engineering evaluation, it was observed that the trigger/slider was blocked, jammed 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 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 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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