FDA Adverse Event
Malfunction
Summary report: N
SD/PD LONG CURVED
MDR report key: 2213837
·
Received August 4, 2011
Report
- Report Number
- 1811755-2011-02812
- Event Type
- Malfunction
- Date Received
- August 4, 2011
- Date of Event
- July 26, 2011
- Report Date
- July 26, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBB
- PMA / PMN Number
- K041754
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DRILL ATTACHMENT WAS RETURNED TO THE MFR, AND THE COMPLAINT WAS CONFIRMED. BASED ON THE DEVICE EVAL, A BROKEN BUR WAS CONFIRMED WITHIN THE DRILL ATTACHMENT. THE CAUSE OF THE BUR BREAKAGE IS UNK.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED FOR REPAIR. DURING THE REPAIR PROCESS, A BROKEN BUR WAS FOUND INSIDE THE DEVICE. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SD/PD LONG CURVED | HBB | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |