IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø10,0X480MM
Received Jan 14, 2016 · Event occurred Dec 9, 2015
Report 0009610622-2016-00015 · MDR key 5368587
Device
Generic name
Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemente
Manufacturer
Stryker Trauma KielCatalog number
02276100
Lot number
K080812
Product problems
- Device Damaged Prior to Use
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE EVALUATION REVEALED ALL REAMERS TO BE THE PRIMARY PRODUCTS. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). THE REAMERS RETURNED WERE DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. AS THE REAMERS HAD BEEN IN USE FOR APPROX. 1.5 YEARS WE PRE-SUPPOSE THAT THEY HAD FULFILLED THEIR TASKS IN FORMER SURGERIES AS INTENDED. DURING THE INVESTIGATION NO MATERIAL, DIMENSIONAL, DESIGN OR MANUFACTURING RELATED ISSUES WERE FOUND. ALL FOUND DEFORMATIONS; DAMAGES AND BREAKAGES INDICATE THAT TOO HIGH ROTATIONAL SPEED WAS PERFORMED TO ALL REAMERS. THE CONSTRICTIONS INDICATE THAT NO GUIDE WIRE WAS USED DURING DRILLING; THE CONSTRICTIONS ARE TOO HEAVY SO THAT AN INSERTED GUIDE WIRE WOULD HAVE JAMMED. FURTHERMORE IT IS NOT POSSIBLE TO DEFORM THE SPIRAL SHAFTS PLASTICALLY IN THAT WAY AS ACTUALLY FOUND WITH INSERTED GUIDE WIRE DURING USE. ADDITIONALLY HITTING MARKS ON THE BIXCUT CUTTING EDGES INDICATE THAT THE REAMERS HIT METAL DURING USAGE. THE REAMERS BROKE DUE A ROTATIONAL AND BENDING OVERLOAD, CONTRIBUTED BY NOT-USING A GUIDE WIRE AND BY HITTING METAL. THE IFU AND OPERATIVE TECHNIQUE INCLUDES SEVERAL WARNINGS TO AVOID REAMER DAMAGES, I.E. THAT REAMING SHALL BE DONE CAREFULLY, NO SPEEDS GREATER THAN 250 RPM SHALL BE PERFORMED, A GUIDE WIRE SHALL BE USED EVERY TIME; DRILLING METAL IS NOT ALLOWED AND THAT ONLY SHARP REAMERS SHALL BE USED. FURTHERMORE REAMING SHALL BE DONE IN 0,5MM STEPS REGARDING THEIR CUTTING DIAMETERS. BECAUSE NO MANUFACTURER RELATED ISSUES WERE FOUND THE DEFORMATIONS AND THE BREAKAGES ARE CAUSED BY A USER ERROR. NO NON-CONFORMITY IDENTIFIED.
Description of Event or Problem
CUSTOMER REPORTED THAT 5 OUT OF 10 REAMERS PURCHASED GOT DAMAGED IN A VERY SHORT PERIOD OF TIME.
Additional Manufacturer Narrative
ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
CUSTOMER REPORTED THAT 5 OUT OF 10 REAMERS PURCHASED GOT DAMAGED IN A VERY SHORT PERIOD OF TIME.