AEZ LONG HANDLE MINI PIN & LIGATURE CUTTER
Received Feb 6, 2013
Report 2016150-2013-00002 · MDR key 2946742
Device
Product problems
- Break
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
A DOCTOR'S OFFICE ALLEGED THAT THE BLADE FROM AN AEZ MINI LIGATURE CUTTER HAD BROKEN OFF OF THE DEVICE DURING A PATIENT'S PROCEDURE.
Additional Manufacturer Narrative
PATIENT DETAILS WITH REGARD TO AGE, GENDER, AND WEIGHT WERE NOT PROVIDED. IT WAS CONFIRMED THAT NO SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT; THE BROKEN PIECE WAS COLLECTED IMMEDIATELY. THE PATIENT WAS NOT HARMED AND IS DOING FINE.A VISUAL TEST WAS PERFORMED ON THE RETURNED DEVICE CONFIRMING THAT THE CUTTING SURFACE HAD BROKEN AWAY FROM THE TIP AND A BRAZE FAILURE HAD OCCURRED; HOWEVER, THE CAUSE OF THE BREAKAGE WAS INCONCLUSIVE. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT NUMBER.