FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
MDR report key: 3831841
·
Received March 6, 2014
Report
- Report Number
- 8031000-2014-00116
- Event Type
- Malfunction
- Date Received
- March 6, 2014
- Date of Event
- February 1, 2014
- Report Date
- February 11, 2014
- Manufacturer
- ZIMMER SURGICAL S.A
- Product Code
- GEY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- 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 MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE DID STOP FREQUENTLY DURING KNEE SURGERY, AND DID NOT WORK AGAIN. SAW ATTACHMENT WAS LOCKED OUT AND DUE TO THAT REASON IT COULD NOT BE CHANGED. THERE WAS NO PATIENT HARM; HOWEVER, THERE WAS A DELAY IN SURGERY FOR APPROXIMATELY 40 MINUTES. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134966 | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE | GEY | ZIMMER SURGICAL S.A | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNIVERSAL OSCILLATING SAW ATTACHMENT 246970 |