|
Model Number PIN, STEINMANN, 2.8 MM |
Device Problem
Material Fragmentation (1261)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/27/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
|
|
Event Description
|
It was reported that during a prosthetic surgery the device produced metal debris.Everything was retrieved from the patient.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
|
|
Search Alerts/Recalls
|
|
|