FDA Adverse Event
Malfunction
Summary report: N
VIT'CANC' SCREW 6.5 DIA X 35MM TRIATHLON TOTAL KNEE
MDR report key: 1951222
·
Received December 13, 2010
Report
- Report Number
- 9616680-2010-00819
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- November 29, 2010
- Report Date
- November 29, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MBH
- PMA / PMN Number
- K072575
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME EVENT AS MFR.#9616680-2010-00820, 9616680-2010-00821.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "UPON OPENING STERILE POUCH NURSE NOTICED HOLES AND INDENTATIONS FROM SCREW THREADS IN POUCH. THE STERILITY OF THESE ITEMS WAS IN QUESTION. THEY WERE NOT USED OR OPENED ONTO THE STERILE FIELD."
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 | 25223101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |