FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL OSCILLATING SAW ATTACHMENT
MDR report key: 3080918
·
Received April 24, 2013
Report
- Report Number
- 8031000-2013-00023
- Event Type
- Malfunction
- Date Received
- April 24, 2013
- Date of Event
- February 18, 2013
- Report Date
- March 25, 2013
- Manufacturer
- ZIMMER SURGICAL S.A.
- Product Code
- HAB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LE
- 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 SURGERY, WHEN PERFORMING THE SECOND FEMORAL CUT, THE BLADE STARTED VIBRATING AND WAS RELEASED. THE LOCKING MECHANISM BECAME NON-FUNCTIONAL ON THE UNIVERSAL OSCILLATING SAW. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 176747 | UNIVERSAL OSCILLATING SAW ATTACHMENT | UNIVERSAL OSCILLATING SAW ATTACHMENT | HAB | ZIMMER SURGICAL S.A. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |