FDA Adverse Event
Malfunction
Summary report: N
2.0MM SMALL-JOINT HOODED ABRASION BUR, FORMULA (5B
MDR report key: 2133224
·
Received May 9, 2011
Report
- Report Number
- 2648666-2011-00130
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- March 29, 2011
- Report Date
- April 13, 2011
- Manufacturer
- STRYKER ENDOSCOPY PUERTO RICO
- Product Code
- HTT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE END OF THE INNER CANNULA BROKE OFF. IT WAS FURTHER REPORTED THAT THE BURR UNIT WILL NOT ENGAGE OR ROTATE. FURTHER, THE ACCOUNT REPORTS THEY EXPERIENCED A SIMILAR FAILURE WITH A SECOND UNIT. FURTHER, METAL FLAKES WERE NOTED IN THE JOINT AFTER USING THE BURR UNITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2.0MM SMALL-JOINT HOODED ABRASION BUR, FORMULA (5B | BUR | HTT | STRYKER ENDOSCOPY PUERTO RICO | 07138CE2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |