Model Number 2440-00-546 |
Device Problems
Dull, Blunt (2407); Failure to Cut (2587)
|
Patient Problem
Not Applicable (3189)
|
Event Date 01/30/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(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
|
They have in consignment 9 stem instrument sets and 6 acetabular instr sets,as they have been waiting for 3 more new acetabular instr sets since (b)(6) 2019.In the meantime, we have left 2 sets of acetabular instruments from oc in order to cover those busy days.They opened those 2 loaners yesterday, and for both of them,the surgeons just could not do the reaming as they said the reamers were totally dull.They had to open zimmer acetabular instruments to finish their surgeries.
|
|
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.
|
|
Manufacturer Narrative
|
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.Product complaint # (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.Depuy-synthes 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.Johnson & johnson (b)(4) reported that reamers are dull.Examination of the returned instrument confirmed the complaint of dullness.The complaint sample consisted of (1) quickset ace grater head 46mm, date code a1210.The date code a1210 indicates that this device was manufactured in dec 2010 and is 9 years old.A search of the complaint database found similar reports and the root cause is attributed to heavy use and wear out.Based on the investigation, the need for corrective action is not indicated.Complaints will be monitored under sep 419 post market surveillance.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Search Alerts/Recalls
|
|