FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL OSCILLATING SAW ATTACHMENT
MDR report key: 4172220
·
Received October 9, 2014
Report
- Report Number
- 8031000-2014-00320
- Event Type
- Malfunction
- Date Received
- October 9, 2014
- Date of Event
- September 19, 2014
- Report Date
- September 24, 2014
- Manufacturer
- ZIMMER SURGICAL S.A.
- Product Code
- GFA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING KNEE PROSTHESIS SURGERY THE SAWBLADE LOOSENS, IT WAS LOCKED IN PLACE AGAIN BUT THE SAME THING HAPPENS. THE NURSE OPENED THE LOCK OF THE BLADE; THE BLADE FALLS OUT (BROKEN) AND SEVERAL PINS FROM THE LOCKING MECHANISM FELL OUT ONTO THE TABLE. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION/ADDITIONAL SURGICAL PROCEDURE; HOWEVER THERE WAS A DELAY IN SURGERY FOR APPROXIMATELY 10 MINUTES. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 636989 | UNIVERSAL OSCILLATING SAW ATTACHMENT | UNIVERSAL OSCILLATING SAW ATTACHMENT | GFA | ZIMMER SURGICAL S.A. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |