SYNTHES GMBH OSCILLATING SAW ATTACHMENT II; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
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Catalog Number 511.801 |
Device Problem
Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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.Additional narrative: concomitant med products and therapy dates: power module device, quick coupling device, k-wire device, (b)(6) 2022.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 (b)(6) that during pre-surgery, it was discovered that the oscillating saw attachment device had an overheating issue while being used together with the power module, quick coupling and k-wire devices.It was further reported that the quick coupling device was not holding the k-wire device, and the power module device was not charging.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no patient involvement reported.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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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.Device evaluation: this device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition of the device having an overheating issue was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device did not function and could not engage the attachment ¿ coupling.It was further determined that the device failed pretest for check the handpiece coupling, check symmetry with handpiece, check function in running mode and check the oscillation frequency with frequency meter.The assignable root cause was determined to be due to component failure from wear.
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Search Alerts/Recalls
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