FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL OSCILLATING SAW ATTACHMENT
MDR report key: 3851065
·
Received February 12, 2014
Report
- Report Number
- 8031000-2014-00068
- Event Type
- Malfunction
- Date Received
- February 12, 2014
- Date of Event
- January 1, 2014
- Report Date
- January 15, 2014
- Manufacturer
- ZIMMER SURGICAL S.A
- Product Code
- GFA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IR
- 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 THE UNIVERSAL OSCILLATING SAW ATTACHMENT HAD ONE PIN ON THE SAW BLADE SHAFT BROKEN. THE SAW BLADE DID NOT OSCILLATE ON THE BONE. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93620 | UNIVERSAL OSCILLATING SAW ATTACHMENT | UNIVERSAL OSCILATING SAW ATTACHMENT | GFA | ZIMMER SURGICAL S.A | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |