Catalog Number UNK PIN GUIDES |
Device Problem
Physical Resistance/Sticking (4012)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/08/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Event Description
|
It was reported that this was an unknown procedure performed on (b)(6) 2020.The 2.5mm guide pin got stuck in the plate (230787003) and was not able to be removed.The procedure was completed without surgical delay.There was no harm to the patient.The device was the first use when issue occurred.
|
|
Manufacturer Narrative
|
Product complaint # : (b)(4).Investigation summary : examination of the returned devices confirmed the guide pin and was jammed/seized in the metaglene positioner plate.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Corrected: h3.
|
|
Manufacturer Narrative
|
Product complaint # : (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.
|
|
Search Alerts/Recalls
|