FDA Adverse Event
Malfunction
Summary report: N
SAGITTAL SAW ATTACHMENT
MDR report key: 2033950
·
Received March 23, 2011
Report
- Report Number
- 1811755-2011-00899
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- October 25, 2010
- Report Date
- October 25, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. BASED ON THE INVESTIGATION DETAILS, THE BEARINGS HAD NO LUBRICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING THE REPAIR PROCESS IN HOUSE. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAGITTAL SAW ATTACHMENT | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |