FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL OSCILLATING SAW ATTACHMENT
MDR report key: 3832877
·
Received March 17, 2014
Report
- Report Number
- 8031000-2014-00155
- Event Type
- Malfunction
- Date Received
- March 17, 2014
- Date of Event
- February 20, 2014
- Report Date
- February 20, 2014
- Manufacturer
- ZIMMER SURGICAL S.A.
- Product Code
- GFA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MFR 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 THE UNIVERSAL OSCILLATING SAW ATTACHMENT DEVICE LOCK MECHANISM BROKE. IT WOULD NOT HOLD THE SAW BLADE IN PLACE. NO ADD'L CLINICAL INFO WAS RECEIVED PRIOR TO THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 156801 | UNIVERSAL OSCILLATING SAW ATTACHMENT | UNIVERSAL OSCILLATING SAW ATTACHMENT | GFA | ZIMMER SURGICAL S.A. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |