SYNTHES GMBH Q-COUPLING FOR KWIRES AND PINSØ1.5-4.0MM; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
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Catalog Number 530.791 |
Device Problems
Mechanical Jam (2983); Complete Loss of Power (4015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
Event Type
malfunction
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Event Description
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It was reported by (b)(6) that during service and evaluation, it was determined that the quick coupling device was frozen/would not move and would not hold k-wire.It was further observed that the k-wire could not be secured/drive.It was further determined that the device failed pretest for check the tool quick coupling, check self-holding force in smallest range, check self-holding force in largest range and check function in running mode.It was noted in the service order that the device was not working.This event did not occur during surgery.There was no patient involvement.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 january 2024.All available information has been disclosed.If additional information should become available, a supplemental medwatch 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: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device being frozen/would not move, identified during service and evaluation was confirmed.The assignable root cause was determined to be due to component failure from normal wear.(b)(4).
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Search Alerts/Recalls
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