FDA Adverse Event
Malfunction
Summary report: N
4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)
MDR report key: 1644554
·
Received March 10, 2010
Report
- Report Number
- 2648666-2010-00150
- Event Type
- Malfunction
- Date Received
- March 10, 2010
- Date of Event
- March 10, 2010
- Report Date
- March 11, 2010
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- FZT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE BEGAN TO PRODUCE METAL SHAVINGS. IT IS FURTHER REPORTED THAT THE SURGEON NOTICED METAL FLAKES DEPOSITED ON THE KNEE SURFACE. THE SURGEON ALLEGEDLY USED A COMPETITORS PRODUCT TO CLEAN THE SURGICAL SITE AND COMPLETE THE PROCEDURE. THE SITE WAS CLEANED AND NO FRAGMENTS REMAINED. IT IS FURTHER REPORTED THAT THE ORIGINAL UNIT IS NOT AVAILABLE FOR THE INVESTIGATION, HOWEVER, THE REMAINDER OF THE BOX WILL BE RETURNED. THERE WERE REPORTEDLY NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX) | CUTTER | FZT | STRYKER ENDOSCOPY PUERTO RICO | 10026CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |