Model Number 2001-48-000 |
Device Problems
Failure to Cut (2587); Contamination /Decontamination Problem (2895)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2022 |
Event Type
malfunction
|
Event Description
|
Four broken hip instruments: medium calcar planar has become dull and teeth are curling over causing bone to be stuck underneath, cs says they are not able to clean throughly white handle cup inserter is cracked and breaking at the handle articulating screw driver has become striped at the tip and is unable to grip screw head size 53 crossback grater broke at the attachment of the cross at all 4 junctions.Broke into two pieces and both pieces were recovered.
|
|
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, no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot, a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
|
|
Search Alerts/Recalls
|
|