FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGITTAL SAW
MDR report key: 2130039
·
Received May 5, 2011
Report
- Report Number
- 1811755-2011-01614
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- April 8, 2011
- Report Date
- April 8, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- HBE
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DURING FAILURE ANALYSIS, THE CUSTOMER'S COMPLAINT WAS NOT DUPLICATED. THE DEVICE FUNCTIONED ACCORDING TO SPECIFICATION. PREVENTIVE MAINTENANCE WAS DONE ON THE BALL BEARING AND THE DEVICE WAS CLEANED, LUBED, ADJUSTED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
THE STRYKER MICRO SAGITTAL SAW WAS SENT IN FOR EVALUATION BECAUSE, IT WAS RUNNING ON ITS OWN. THERE WAS NO PT INVOLVEMENT; 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 |