Model Number N/A |
Device Problem
Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/13/2024 |
Event Type
malfunction
|
Event Description
|
It was reported that the tip of the depth gauge broke.There was no known impact or consequences to the patient.It was reported that no further information was available.
|
|
Manufacturer Narrative
|
(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
|
Event Description
|
No further information at the time of this report.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified the device had fractured at a notch location on the tip.There is scuffing to the handle and a bend to the tip below the fracture site.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|
|
Search Alerts/Recalls
|