SWIVEL CLAMP BAR
Received Jun 12, 2009 · Event occurred Apr 1, 2006
Report 1035617-2009-00012 · MDR key 1475792
Device
Generic name
Swivel Clamp Bar
Manufacturer
Zimmer Orthopaedic Surgical ProductsModel number
NACatalog number
00-1042-003-00
Lot number
NA
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER REPORTED NINE INCIDENTS OF BROKEN CLAMPS ON THE 48" SWIVEL CLAMP BAR. THERE WAS NO REPORT OF PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE INCIDENTS.
Additional Manufacturer Narrative
VISUAL INSPECTION OF THE RETURNED DEVICES CONFIRMED THAT THE CLAMPS WERE BROKEN. THIS MEDWATCH IS BEING SUBMITTED LATE, AS IT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED PURSUANT TO A FDA INSPECTION AT THE MFR'S FACILITY IN JAN, 2008, AND IN RESPONSE TO AN INSPECTIONAL OBSERVATION. THE AGENCY'S INSPECTIONAL OBSERVATION CONCERNED THE MFR'S DECISION NOT TO SUBMIT MDRS FOR CERTAIN EVENTS INVOLVING PRODUCT MANUFACTURED AT THE FACILITY.