FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL RECIPROCATING SAW ATTACHMENT
MDR report key: 3113117
·
Received May 9, 2013
Report
- Report Number
- 8031000-2013-00027
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 15, 2013
- Report Date
- April 15, 2013
- Manufacturer
- ZIMMER SURGICAL S.A.
- Product Code
- HAB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A REVISION TOTAL KNEE REPLACEMENT, THE UNIVERSAL RECIPROCATING SAW ATTACHMENT EASILY RELEASED THE BLADE, LEAVING IT IN THE SURGICAL SITE AFTER APPROXIMATELY 6.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204968 | UNIVERSAL RECIPROCATING SAW ATTACHMENT | NONE | HAB | ZIMMER SURGICAL S.A. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | SYNVASIVE DOUBLE SIDED RECIPROCATING BLADE:| (B)(4) |