This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.Reliability engineering evaluated the device and the reported condition was confirmed.The assignable root cause was determined to be due to false constructive design.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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It was reported from (b)(6) that during service and repair, it was observed that the recon sagittal saw with key for trs had been found with the trigger / slider broken, and magnet holder of trigger broken, due to faulty construction and design.This event was not related to surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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