FDA Adverse Event
Malfunction
Summary report: N
"ACORN BUR, TOOLSTEEL, LONG"
MDR report key: 1550800
·
Received November 19, 2009
Report
- Report Number
- 9616696-2009-00219
- Event Type
- Malfunction
- Date Received
- November 19, 2009
- Date of Event
- July 18, 2006
- Report Date
- July 18, 2006
- Manufacturer
- STRYKER IRELAND LTD
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A NUMBER OF BURS WHICH WERE SUBJECT TO THIS COMPLAINT WERE RETURNED FOR EVAL. THEY WERE EXAMINED AND FOUND TO BE WITHIN SPECIFICATION REQUIREMENTS. HOWEVER, FURTHER INVESTIGATION INDICATED A DEFICIENCY IN THE DESIGN SPECIFICATION TO SPECIFY THE RELIEF START POSITION. THIS ISSUE HAS SINCE BEEN ADDRESSED AND A NEW SPECIFICATION PUT IN PLACE.
Description of Event or Problem · 1
IT WAS REPORTED THAT BURS (PART NO. 5230-030-060) ARE DULLING UPON USE. IT WAS ALSO REPORTED THAT MULTIPLE BURS ARE HAVING TO BE USED THROUGHOUT SURGICAL PROCEDURES. NO ADVERSE CONSEQUENCES ARE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | "ACORN BUR, TOOLSTEEL, LONG" | SURGICAL BURS, DRILLS TREPHINES & ACCESSORIES | HBE | STRYKER IRELAND LTD | 06101017 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |