FDA Adverse Event
Malfunction
Summary report: N
TIBIAL ALIGNMENT HANDLE
MDR report key: 2220593
·
Received July 15, 2011
Report
- Report Number
- 2249697-2011-01070
- Event Type
- Malfunction
- Date Received
- July 15, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 22, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE MANUFACTURE DATE FOR LOT # N2H10: 05/23/2007. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THIS IS THE SAME EVENT AS: MFR # 2249697-2011-01069, MFR # 2249697-2011-01071, MFR # 2249697-2011-01072. ADDITIONAL LOT #: N2H10.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THESE TRIATHLON INSTRUMENTS WERE LEFT IN THE AUTOCLAVE FOR APPROX 12 HOURS AND HAVE A FILMY RESIDUE. THE INSTRUMENTS WERE NOT LEFT TO SIT FOR 1 HOUR AFTER AUTOCLAVE AS SPECIFIED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TIBIAL ALIGNMENT HANDLE | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS MAHWAH | NA | NZV09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |