MalfunctionHXY
UNI-CLIP DRILL GUIDE
Received Dec 21, 2011 · Event occurred Nov 28, 2011
Report 9615741-2011-00072 · MDR key 2419022
Device
Generic name
Uni-clip
Manufacturer
Newdeal S.a.Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE REPORTER STATED THAT DURING A FOREFOOT SURGICAL PROCEDURE TO INTRODUCE A UNI CLIP COMPRESSION PLATE, THE DRILL GUIDE SNAPPED AND BROKE MAKING IT UNSUITABLE FOR CONTINUED USE. THE HOSPITAL HAD ANOTHER INSTRUMENT SET WHICH WAS OPENED TO COMPLETE THE SURGERY. THERE WAS NO ADVERSE OUTCOME FOR THE PT.
Additional Manufacturer Narrative
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.