Model Number 2544-01-015 |
Device Problems
Break (1069); Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/06/2020 |
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 spacer base shims would not seat flush into the spacer block.Trial extractor tip was broken while removing trial.All parts/pieces were accounted for and removed from the field.
|
|
Manufacturer Narrative
|
Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about 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.
|
|
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.
|
|
Event Description
|
Additional information received that the instrument broke into two pieces and all parts were accounted for and removed from the sterile field.
|
|
Search Alerts/Recalls
|