FDA Adverse Event
Malfunction
Summary report: N
SABO SAG SAW
MDR report key: 1892530
·
Received November 2, 2010
Report
- Report Number
- 1811755-2010-01585
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- October 9, 2010
- Report Date
- October 11, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR SERVICE AND EVAL. A CONDITION OF THE DEVICE OVERHEATING WAS FOUND AND THEN REPORTED. BASED ON THE INVESTIGATION DETAILS, THE INDEX PART OF THE DEVICE HEAD BECAME HOT DURING TESTING. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.
Description of Event or Problem · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR. DURING THE REPAIR, IT WAS REPORTED THAT THE HANDPIECE EXCEEDED MAXIMUM TEMPERATURE DURING TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SABO SAG SAW | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |