DEPUY SYNTHES PRODUCTS LLC KINCISE¿ PINNACLE® SHELL/LINER IMPACTOR; MOTOR, SURGICAL INSTRUMENT, AC-POWERED
|
Back to Search Results |
|
Model Number 1011-01-101 |
Device Problems
Fracture (1260); Material Fragmentation (1261)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/21/2023 |
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, an evaluation was performed and it was determined that the t-handle being broken, identified during service and evaluation was confirmed.The assignable root cause was determined to be traced to user, which is user error/ improper handling.Udi: (b)(4).
|
|
Event Description
|
It was reported that during an unspecified surgical procedure, it was discovered that the cup-adapter device broke at the vase (cross).The reporter further clarified that the device was cracked.During in-house engineering evaluation, it was observed that the device was broken at the t-handle, which was consistent with it being dropped or experiencing other radial force.The device was visually inspected, and it was found that the device failed visual inspection.It was further determined that the device failed pretest for visual assessment.It was reported that there were no delays in the surgical procedure.It was not reported if a spare device was available for use.There was 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.
|
|
Search Alerts/Recalls
|
|
|