FDA Adverse Event
Malfunction
Summary report: N
EXTRA LONG STRAIGHT SABER ATTACHMENT
MDR report key: 2223268
·
Received August 16, 2011
Report
- Report Number
- 1811755-2011-03012
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 28, 2011
- Report Date
- July 28, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DRILL ATTACHMENT WAS RETURNED TO THE MANUFACTURER AND THE COMPLAINT WAS CONFIRMED. INTERNAL COMPONENTS WERE EVALUATED, WHICH REVEALED CORRODED BEARINGS AND FOREIGN DEBRIS CONTAMINATION. THE PRESENCE OF CORROSION AND DEBRIS CAN LEAD TO INCREASED FRICTION AMONG ROTATING COMPONENTS, RESULTING IN HEAT BEING GENERATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING TESTING CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN, THE DRILL ATTACHMENT WAS GETTING OVER-HEATED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PATIENT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTRA LONG STRAIGHT SABER ATTACHMENT | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |