FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN_INSTRUMENTS_PRODUCT
MDR report key: 3110499
·
Received May 14, 2013
Report
- Report Number
- 0001811755-2013-01104
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 15, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY, A BROKEN BUR WAS FOUND INSIDE THE ATTACHMENT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING AT THE MANUFACTURER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 212885 | UNKNOWN_INSTRUMENTS_PRODUCT | DRILLS, BURRS, TREPHINES & ACCESSORIES | HBE | STRYKER INSTRUMENTS-KALAMAZOO | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4), LOT 12181 |