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