FDA Adverse Event
Malfunction
Summary report: N
REPAIR TPS SAG SAW
MDR report key: 1854391
·
Received September 30, 2010
Report
- Report Number
- 1811755-2010-01275
- Event Type
- Malfunction
- Date Received
- September 30, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 7, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- DZJ
- PMA / PMN Number
- K040369
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS BEEN REC'D AT THE MFR FOR INVESTIGATION. AN EVAL WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE BLADE MOUNT GAP WAS TOO TIGHT, THE BEARINGS WERE WORN, AND CORROSION WAS FOUND IN THE MOTOR AND PINS. THE MOTOR CARTRIDGE, BLADE MOUNT AND BEARINGS WERE REPLACED, ALONG WITH OTHER COMPONENTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE OVERHEATED. THIS WAS NOT FOUND DURING A SURGICAL PROCEDURE. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPAIR TPS SAG SAW | BONE CUTTING INSTRUMENT AND ACCESSORIES | DZJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |