FDA Adverse Event
Malfunction
Summary report: N
BRASSELER USA SURGICAL BUR
MDR report key: 7835091
·
Received August 30, 2018
Report
- Report Number
- 2025102-2018-00008
- Event Type
- Malfunction
- Date Received
- August 30, 2018
- Report Date
- August 30, 2018
- Manufacturer
- BRASSELER U.S.A. MEDICAL, LLC
- Product Code
- GFF
- PMA / PMN Number
- K883255
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT WAS RETURNED AND NO LOT NUMBER PROVIDED. FOLLOW UP WITH THE INITIAL REPORTER FOUND THE BUR WAS USED WITH A DRILL AND POWER SYSTEM THAT ARE NOT IDENTIFIED AS COMPATIBLE WITH THIS BUR.
Description of Event or Problem · 1
IN (B)(6) 2018, DURING THE LEFT TOTAL KNEE ARTHROPLASTY A 4.0 MM STANDARD BUR REF #(B)(4) BROKE. THE BROKEN BUR WAS SEQUESTERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673065 | BRASSELER USA SURGICAL BUR | SURGICAL BUR | GFF | BRASSELER U.S.A. MEDICAL, LLC | 16-C0901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |