FDA Adverse Event
Malfunction
Summary report: N
BUR, SURGICAL, GENERAL AND PLASTIC SURGERY
MDR report key: 17522567
·
Received August 12, 2023
Report
- Report Number
- MW5129515
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- March 23, 2017
- Manufacturer
- BRASSELER
- Product Code
- GFF
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER A BROKEN BUR WAS FOUND INSIDE THE STRYKER ATTACHMENT (5100015250 LOT 0303405423). IT WAS ALSO REPORTED THAT THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE AND THERE WAS NO DELAY OR ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT. ON (B)(6) 2017, STRYKER INSTRUMENTS ALSO REPORTED THE SAME INFORMATION TO BRASSELER. PI-1436524. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 870264 | BUR, SURGICAL, GENERAL AND PLASTIC SURGERY | BUR, SURGICAL, GENERAL AND PLASTIC SURGERY | GFF | BRASSELER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |