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 reported condition was confirmed.The assignable root cause was determined to be due to component failure from normal wear.Udi: (b)(4).
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It was reported from (b)(6) that the color finish on the housing of the compact speed reducer device was faded and damaged.During in-house engineering evaluation, it was observed that the device had cosmetic damage ¿ worn, a bent drive shaft, vibration, and a worn gear.It was further determined that the device failed pretest for visual assessment.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 surgical procedure or if a spare device was available for use.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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