KERRISON DETACH 130DG UP 200MM 1MM THIN
Received Oct 9, 2015
Report 2916714-2015-00898 · MDR key 5140748
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). MANUFACTURING SITE EVALUATION: ONE FK961B / BATCH NUMBER 52018777 / MANUFACTURING DATE 04/01/2015 RECEIVED FOR EVALUATION. THE TIP OF DEVICE IS BROKEN OFF AND WAS NOT RETURNED FOR EVALUATION. MICROSCOPIC ANALYSIS OF THE FRACTURE INDICATES A PATTERN OF FORCED FRACTURE DUE TO OVERLOAD; NO PORES, INCLUSIONS OR FOREIGN BODIES WERE FOUND AT THE POINT OF RUPTURE. THE PUSHER EXHIBITS INDICATIONS OF WEAR AND TEAR. HARDNESS TESTING CONFIRMED THAT THE DEVICE MATERIAL HARDNESS IS ACCORDING TO SPECIFICATION. REVIEW OF QUALITY AND MANUFACTURING DOCUMENTS HAS BEEN COMPLETED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. THIS TYPE OF INSTRUMENT IS DESIGNED FOR DELICATE USE. THE NOTED MECHANICAL OVERLOAD LED TO THE BREAKAGE, WHICH IS CONFIRMED BY THE DEFORMED PUSHER. BASED ON THIS INFORMATION, IT IS DETERMINED THAT THE ROOT CAUSE USER RELATED. CORRECTIVE / PREVENTIVE ACTION: NOT APPLICABLE.
Additional Manufacturer Narrative
MANUFACTURING SITE EVALUATION IS ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). INTRA-OPERATIVE BREAK OF WORKING END OF KERRISON PUNCH.