FDA Adverse Event
Malfunction
Summary report: N
REPAIR CORE SAG SAW
MDR report key: 1983970
·
Received January 11, 2011
Report
- Report Number
- 1811755-2011-00075
- Event Type
- Malfunction
- Date Received
- January 11, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 16, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR EVALUATION, AND THE REPORTED CONDITION OF THE DEVICE OVERHEATING WAS DUPLICATED. BASED ON THE INVESTIGATION DETAILS, THE LIKELY CAUSE WAS A CORRODED MOTOR AND PRESS PLUG. THOSE PARTS WERE BOTH REPLACED ALONG WITH OTHER COMPONENTS. SERVICE DID A CLEAN, LUBE, AND ADJUST TO THE DEVICE, AND IT WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING A SURGICAL PROCEDURE. THE CASE WAS SUCCESSFULLY 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 | REPAIR CORE SAG SAW | SURGICAL INSTRUMENT MOTORS AND ACESSORIES/ATTAC | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |