QUICK CONNECT HANDLE
Received May 24, 2016 · Event occurred Apr 26, 2016
Report 0002249697-2016-01679 · MDR key 5675786
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous
Manufacturer
Stryker Orthopaedics-mahwahCatalog number
1440-1040
Lot number
TAZN311
Product problems
- Break
- Material Integrity Problem
- Material Integrity Problem
Patient
55 YR
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
- No Consequences Or Impact To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
AN EVENT REGARDING CRACK/FRACTURE INVOLVING A QUICK CONNECT HANDLE WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE¿S BODY FRACTURED IN OVERLOAD. THE DEFORMATION ON THE PLUNGER SHAFT LIKELY OCCURRED WHILE THE TIP OF THE BODY FRACTURED. THE BALL BEARING OF THE DEVICE WAS NOT RETURNED, LIKELY FALLING OUT WHEN THE BODY FRACTURED. EDS CONFIRMED THE BASE ALLOY OF THE DEVICE TO BE CONSISTENT WITH 17-4 PH STAINLESS STEEL ALLOY. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. MEDICAL RECORDS RECEIVED AND EVALUATION: NOT PERFORMED AS MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT CRACK/FRACTURE WAS CAUSED BY THE DEVICE¿S BODY FRACTURE IN OVERLOAD. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED.
Description of Event or Problem
IT WAS REPORTED, "SURGEON WAS USING THE DIRECT ANTERIOR LEFT FEMORAL BROACH HANDLE WITH THE ANTEVERSION HANDLE ATTACHMENT. CAT#1440-1040 LOT #TAXN311. THE TIP BROKE OFF WHEN FORCE WAS APPLIED. THE INSTRUMENT WAS IMMEDIATELY REMOVED FROM THE FIELD AND IS BEING RETURNED FOR INSPECTION. THE SMALL BROKEN PART WAS LOST AS IT WENT THROUGH THE WASHER STERILIZER IN PROCESSING. WAS UNABLE TO LOCATE. THERE WAS NO COMPROMISE TO THE PATIENT AND THE SURGERY WAS COMPLETED WITHOUT DELAY."
Additional Manufacturer Narrative
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED, "SURGEON WAS USING THE DIRECT ANTERIOR LEFT FEMORAL BROACH HANDLE WITH THE ANTEVERSION HANDLE ATTACHMENT. CAT#1440-1040, LOT #TAXN311. THE TIP BROKE OFF WHEN FORCE WAS APPLIED. THE INSTRUMENT WAS IMMEDIATELY REMOVED FROM THE FIELD AND IS BEING RETURNED FOR INSPECTION. THE SMALL BROKEN PART WAS LOST AS IT WENT THROUGH THE WASHER STERILIZER IN PROCESSING. WAS UNABLE TO LOCATE. THERE WAS NO COMPROMISE TO THE PATIENT AND THE SURGERY WAS COMPLETED WITHOUT DELAY."