FDA Adverse Event
Malfunction
Summary report: N
SAGITTAL SAW ATTACHMENT
MDR report key: 2042809
·
Received March 30, 2011
Report
- Report Number
- 1811755-2011-01016
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 7, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GET
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED. ACCORDING TO THE INVESTIGATION DETAILS THE BEARINGS NEEDED TO BE REPLACED. THE DETAILS WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE OVERHEATED DURING TESTING DURING ROUTINE MAINTENANCE VISIT AT THE ACCOUNT. THIS DID NOT OCCUR DURING ANY SURGICAL PROCEDURE AND NO ADVERSE CONSEQUENCES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAGITTAL SAW ATTACHMENT | GET | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |