DEPUY SYNTHES PRODUCTS LLC RECIPROCATING MICRO SAW; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Model Number R-SAW |
Device Problems
Overheating of Device (1437); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the device not working was not confirmed.Therefore, an assignable root cause was not determined.However, the reported condition of heat was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was determined that the reciprocating micro saw device had a component damage, and it generated heat.It was further observed that the jaw was loose from the chuck.It was further determined that the device failed pretest for visual assessment and temperature assessment.It was noted in the service order that during pre-surgery, it was discovered that the device did not work.It was reported that there were no delays in the surgical procedure.It was not reported if a spare device was available for use.There was no patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2021.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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