FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 1842092
·
Received August 26, 2010
Report
- Report Number
- 1811755-2010-01021
- Event Type
- Malfunction
- Date Received
- August 26, 2010
- Date of Event
- August 10, 2010
- Report Date
- August 10, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MFR FOR EVAL, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS PROBLEMS WITH THE SAG HEAD ASSEMBLY, ROTOR, AND MOTOR, WHICH WERE EACH REPLACED ALONG WITH BEARINGS AND OTHER COMPONENTS. SERVICE REPAIRED AND RETURNED THE DEVICE TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING A SURGICAL PROCEDURE. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | SURGICAL INSTRUMENT MOTORS AND ACCESSORIES/ATTAC | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |