|
Model Number PHALANGEAL REAMER, 18MM |
Device Problem
Dull, Blunt (2407)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/08/2023 |
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
|
On 8/8/2023, it was reported by a sales representative via sems the following: an ar-8944mr-18 metatarsal reamer (batch#041309) is getting dull.An ar-8944mr-20 metatarsal reamer (batch#041329) is getting dull.An ar-8944mr-22 metatarsal reamer (batch#041302) is getting dull.An ar-8944pr-18 phalangeal reamer (batch#041308) is getting dull.An ar-8944pr-20 phalangeal reamer (batch#041326) is getting dull.An ar-8944pr-22 phalangeal reamer (batch #041309) is getting dull.This was discovered during an unspecified procedure, with no adverse event or patient harm.
|
|
Search Alerts/Recalls
|
|
|