DEPUY SYNTHES PRODUCTS LLC LID FOR RECON SAGITTAL SAW FOR TRS; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 05.001.241 |
Device Problems
Defective Component (2292); Naturally Worn (2988)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6). this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was confirmed.The assignable root cause was determined to be due to improper maintenance, which is user error/misuse/abuse.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Event Description
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It was reported from (b)(6) that during service and evaluation, it was determined that the lid device locking mechanism was defective an the coupling tool side did not function.It was further determined that the device failed pretest for check function of mode switch lever, check torque of mode switch, check function ¿lock/unlock¿ with safety button and check the locking function with handpiece.It was noted in the service order that the device had a damaged hose.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Search Alerts/Recalls
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