FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 2082072
·
Received April 26, 2011
Report
- Report Number
- 1811755-2011-01427
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- March 29, 2011
- Report Date
- March 29, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING QUALITY INVESTIGATION, THE CUSTOMER'S COMPLAINT WAS NOT DUPLICATED AS THE DEVICE HAD NO POWER. UPON DISASSEMBLY OF THE DEVICE A DAMAGED MOTOR AND PRESS PLUG WAS NOTED. CORROSION DAMAGE TO THE MOTOR WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE. THE DAMAGED PARTS WERE REPLACED, PREVENTIVE MAINTENANCE DONE AND THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE MICRO SAGITTAL SAW WAS SENT IN FOR REPAIR BECAUSE IT WAS RUNNING WITHOUT ACTIVATION. THE EVENT OCCURRED DURING A ROUTINE MAINTENANCE TESTING; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO SAGITTAL SAW | HBE | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |