PIN,PASSING,DRILL TIP 2.4X381MM,STRL
Received Sep 14, 2016 · Event occurred Mar 24, 2014
Report 1219602-2016-00609 · MDR key 5948394
Device
Generic name
Guide, Drill, Ligament
Manufacturer
Smith & Nephew, Inc.Catalog number
7208678
Lot number
50492240
Product problems
- Break
Patient
20 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(6). VISUAL INSPECTION CONFIRMED THE REPORTED COMPLAINT. THE PASSING PIN WAS BROKEN 3CM FROM THE DISTAL TIP. AN EXACT ROOT CAUSE FOR THE BREAKAGE COULD NOT BE DETERMINED WITH CONFIDENCE, HOWEVER, FURTHER INVESTIGATION FOUND TORSIONAL FORCE AT THE AREA OF THE BREAK. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED NO INCONSISTENCIES. THERE WERE NO INTERNAL PROCESSING ISSUES, WHICH COULD HAVE CONTRIBUTED TO THE NATURE OF THE COMPLAINT. A COMPLAINT HISTORY REVIEW HAS NOT IDENTIFIED ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER ON FILE. THERE ARE NO INDICATIONS THAT WOULD SUGGEST THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION.
Description of Event or Problem
IT WAS REPORTED THAT THE PASSING PIN BROKE IN TWO WHILE DRILLING THE FEMORAL TUNNEL. BOTH PIECES WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED.