FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL RECIPROCATING SAW ATTACHMENT
MDR report key: 3250295
·
Received July 24, 2013
Report
- Report Number
- 8031000-2013-00136
- Event Type
- Malfunction
- Date Received
- July 24, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 26, 2013
- Manufacturer
- ZIMMER SURGICAL S.A
- Product Code
- KIJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IR
- Reporter Occupation
- UNKNOWN
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 RECIPROCATING SAW ATTACHMENT DOES NOT RECIPROCATE. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 344881 | UNIVERSAL RECIPROCATING SAW ATTACHMENT | UNIVERSAL RECIPROCATING SAW ATTACHMENT | KIJ | ZIMMER SURGICAL S.A | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |