MalfunctionMAY
IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø10,0X480MM
Received Nov 17, 2017 · Event occurred Oct 11, 2017
Report 0009610622-2017-00357 · MDR key 7041004
Device
Generic name
Hip Joint Metal/ceramic/polymer Semi-constrained Cemented Or Nonporous Uncemente
Manufacturer
Stryker Trauma KielCatalog number
02276100
Lot number
K024270
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED BY THE BIOMEDICAL ENGINEER AT THE HOSPITAL THAT DURING A TOTAL HIP SURGERY PERFORMED BY DR. (B)(6), THE REAMER BROKE WHEN REAMING THE FEMUR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE REAMER BY A NEW ONE.