FDA Adverse Event
Malfunction
Summary report: N
SD/PD MEDIUM CURVED
MDR report key: 2132378
·
Received June 13, 2011
Report
- Report Number
- 1811755-2011-02156
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 13, 2011
- Report Date
- May 16, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE CAUSE OF THE BUR BREAKAGE IS UNKNOWN. THE DEVICE COULD NOT BE REPAIRED AND THEREFORE WAS NOT RETURNED TO THE USER FACILITY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BUR WAS STUCK IN THE DEVICE. THIS WAS DISCOVERED AFTER A PROCEDURE. IT WAS FOUND DURING SERVICE THAT THE BUR WAS BROKE INSIDE OF THE DEVICE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SD/PD MEDIUM CURVED | HBE | STRYKER INSTRUMENTS KALAMAZOO | 10198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |