SYNTHES GMBH QUICK COUPLING FOR K-WIRES; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Catalog Number 532.022 |
Device Problems
Noise, Audible (3273); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
malfunction
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Event Description
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It was reported from (b)(6) that during post-surgery, it was discovered that the quick coupling device was overheating and making a strange noise.The event was not related to surgery.There was no 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 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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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.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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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: the actual device was returned for evaluation.During repair, it was determined that the reported condition of device overheating and making a strange noise was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the quick coupling device could not secure/drive k-wire, did not function, would not hold k-wire, had worn bearing and had component damage.It was further determined that the device failed pretest for general condition, checking the quick coupling for k-wire, checking self-holding force in smallest range, checking self-holding force in largest range, and checking function in running mode.The assignable root cause was determined to be traced to maintenance, which is improper maintenance.
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