FDA Adverse Event
Malfunction
Summary report: N
STRYKER PRECISION THIN SAW BLADE
MDR report key: 10792225
·
Received November 5, 2020
Report
- Report Number
- 10792225
- Event Type
- Malfunction
- Date Received
- November 5, 2020
- Date of Event
- October 19, 2020
- Report Date
- October 19, 2020
- Manufacturer
- STRYKER CORPORATION
- Product Code
- GFA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
WHEN USING SAW TO TAKE THE BONE TENDON BONE GRAFT, THE SAW BLADE BROKE AT THE SITE OF ATTACHMENT TO THE SAW ITSELF. SAW CAME APART IN 3 PIECES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1261373 | STRYKER PRECISION THIN SAW BLADE | BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | GFA | STRYKER CORPORATION | 2296-003-111 | 20177037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5840 DA |