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Catalog Number 530.710 |
Device Problems
Output below Specifications (3004); Complete Loss of Power (4015); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi: (b)(4).
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Event Description
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It was reported from thailand that during an unspecified surgical procedure, it was discovered that the battery oscillator device did not have enough power to cut the bone.It was further reported that when the device was used for a while, it heated up and turned off.It was reported that when the device was cooled down, it worked, but could not cut the bone, and then stopped working.It was reported that there were no delays to the surgical procedure as a spare device was available to complete the surgery.There was 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 2022.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.H10 additional narrative: the actual device was returned for evaluation.The battery oscillator device was evaluated and the reported condition that the device heated up after use for a while was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device had a sticky trigger, the saw head positioning was not smooth, and the handpiece would not run.It was further determined that the device failed pretest for check positioning of the saw head, check for sticky triggers, check the function of the device, and check oscillation frequency with frequency meter.The assignable root cause of this condition was determined to be traced to component failure due to wear.
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Search Alerts/Recalls
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