Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once the evaluation has been completed, a supplemental medwatch report will be sent accordingly. 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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It was reported that during an unspecified surgical procedure, it was observed that the top pins on the battery oscillator device had fallen off.It was reported that one pin was recovered while two other pins were not recovered.An xray was taken to verify and confirm that the pins were not in the patient.It was reported that the patient had prolonged anesthesia while awaiting the xray results, however the duration was not specified.There was patient involvement.There were no reports of injuries or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Corrected data, d10, the date the device was returned to the manufacturer was reported as february 7, 2020 in the initial report and has been updated to february 6, 2020.The actual device was returned for evaluation.Quality engineering evaluated the device and it was determined that the device had a worn oscillator head with broken pins, there was an unknown liquid inside of the electronic control unit cavity, an unknown liquid coming out from the slid sleeve while running and the thrust disk had excessive play.It was further determined that the device failed pretest for general condition and check saw blade coupling.Therefore, the reported condition was confirmed.A device history review was performed which indicated that there were no relevant issues identified during the manufacture of the device that may have contributed to the reported condition.The assignable root cause for the broken pins was determined to be associated with a design issue that has been escalated to a capa.The root cause for the unknown liquid was due to improper cleaning/maintenance.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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