FDA Adverse Event
Malfunction
Summary report: N
U2 STRAIGHT LONG AM ATTACHMENT
MDR report key: 2241657
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03197
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 13, 2011
- Report Date
- August 13, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 FOREIGN DEBRIS CONTAMINATION WITHIN THE DEVICE, INCLUDING THE BEARINGS. THE PRESENCE OF 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 FIELD SERVICE TECHNICIAN, THE DEVICE OVER-HEATED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT 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 | U2 STRAIGHT LONG AM ATTACHMENT | ERL | STRYKER INSTRUMENTS KALAMAZOO | 06331 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |