Model Number 2217-50-001 |
Device Problem
Mechanical Jam (2983)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/11/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that the liner extractor not working.Bar not sliding or moving when wheel is turned.Could not remove liner during revision.Back up plan was screw used to remove liner.There was a five minute surgical delay.
|
|
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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary the device associated with this complaint was not returned.Photo evidence provided was reviewed and found no visible damage that could confirm a device issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation mre was not performed.
|
|
Manufacturer Narrative
|
Product complaint (b)(4).Investigation summary the device associated with this report was returned to depuy synthes for evaluation.Visual inspection of the returned device found the tip of the device bent.However, the functional test was unable to replicate the reported condition.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a date code was provided, which indicates that the device was manufactured on 12/10.A manufacturing records evaluation (mre) was not performed since a valid finished good lot number was not provided for this device.
|
|
Search Alerts/Recalls
|