FDA Adverse Event
Malfunction
Summary report: N
VIT'CANC' SCREW 6.5 DIA X 35MM TRIATHLON TOTAL KNEE
MDR report key: 2091060
·
Received May 12, 2011
Report
- Report Number
- 9616680-2011-00303
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 20, 2011
- Report Date
- April 20, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MBH
- PMA / PMN Number
- K072575
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE DRILL THAT IS USED IS CALIBRATED. WHEN THE DRILL WENT THROUGH THE DRILL GUIDE, IT SHOWED A READING OF 35MM. THE SCREWS WERE TOO LONG. THE REST OF THE CASE, THE DOCTOR DRILLED THEN USED A DEPTH GAUGE TO MEASURE. THE REST OF THE CASE WENT FINE. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VIT'CANC' SCREW 6.5 DIA X 35MM TRIATHLON TOTAL KNEE | IMPLANT | MBH | STRYKER ORTHOPAEDICS CORK | NA | 35931501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |