|
Catalog Number 05.001.201 |
Device Problems
Circuit Failure (1089); Physical Resistance/Sticking (4012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/06/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
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, it was determined that the reported condition that the device did not recognize the batteries was not confirmed.Therefore, an assignable root cause for the reported condition of contact damage was not determined.However, during evaluation, it was determined that the reported condition that the device had a sticky trigger was confirmed.The assignable root cause was determined to be traced to maintenance.Udi: (b)(4).
|
|
Event Description
|
It was reported by germany that during service and evaluation, it was determined that the battery handpiece device had worn housing, leak tightness test failure, sticky trigger, would not run and had illegible labeling etch.It was further determined that the device failed pretest for general condition, markings, leakage test using bubble emission technique, check for mechanical free moving, check for sticky triggers, check falling out protection, check for wear on housing and check general function of device.It was noted in the service order that the device did not recognize the batteries.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should available, a supplemental medwatch will be submitted accordingly.
|
|
Search Alerts/Recalls
|
|
|