FDA Adverse Event
Malfunction
Summary report: N
ELITE 12CM STRAIGHT ATTACHMENT
MDR report key: 6092782
·
Received November 10, 2016
Report
- Report Number
- 0001811755-2016-02710
- Event Type
- Malfunction
- Date Received
- November 10, 2016
- Date of Event
- November 7, 2016
- Report Date
- November 7, 2016
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K143320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED AT THE MANUFACTURER FACILITY PAINT CHIPS WERE MISSING FROM THE DEVICE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 744751 | ELITE 12CM STRAIGHT ATTACHMENT | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | HBE | STRYKER INSTRUMENTS-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |