ACCOLADE OFFSET RASP HANDLE
Received Apr 22, 2016 · Event occurred Mar 28, 2016
Report 0002249697-2016-01290 · MDR key 5597890
Device
Generic name
Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous
Manufacturer
Stryker Orthopaedics-mahwahCatalog number
1020-1400
Lot number
UNKNOWN
Product problems
- Break
- Device Dislodged or Dislocated
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
67 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
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
WHILE SURGEON WAS PREPARING THE FEMUR FOR THE EXETER PROSTHESIS, THE EXETER MODULAR BROACH BROKE OFF/DISENGAGED FROM THE BROACH HANDLE RESULTING IN THE BROACH BEING LEFT IN SITU UNTIL THE SURGEON EVENTUALLY WAS ABLE TO REMOVE THE BROACH AND COMPLETE THE TOTAL HIP PROCEDURE.
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR EVALUATION. AN EVENT REGARDING CRACKING/FRACTURING INVOLVING AN ACCOLADE HANDLE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, PRE- AND POST-OP X-RAYS, PATIENT HISTORY, HISTOPATHOLOGY REPORT & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.
Description of Event or Problem
WHILE SURGEON WAS PREPARING THE FEMUR FOR THE EXETER PROSTHESIS, THE EXETER MODULAR BROACH BROKE OFF/DISENGAGED FROM THE BROACH HANDLE RESULTING IN THE BROACH BEING LEFT IN SITU UNTIL THE SURGEON EVENTUALLY WAS ABLE TO REMOVE THE BROACH AND COMPLETE THE TOTAL HIP PROCEDURE.