FDA Adverse Event
Injury
Summary report: N
STRYKER INSTRUMENTS
MDR report key: 752744
·
Received July 7, 2005
Report
- Report Number
- MW1036009
- Event Type
- Injury
- Date Received
- July 7, 2005
- Date of Event
- June 9, 2005
- Report Date
- June 24, 2005
- Manufacturer
- STRYKER INSTRUMENTS
- Product Code
- HWE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
SAW BLADE BROKE DURING TKR AND ONE PIECE REMAINED MISSING. PHYSICIAN REFUSED X-RAY. NO PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STRYKER INSTRUMENTS | SAGITTAL BLADE | HWE | STRYKER INSTRUMENTS | 2108-150 | 3100501 10505 12277T |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |