OFFSET DOUBLE CLAMP BAR
Received Jun 12, 2009 · Event occurred Aug 1, 2007
Report 1035617-2009-00029 · MDR key 1475801
Device
Generic name
Offset Double Clamp Bar
Manufacturer
Zimmer Orthopaedic Surgical ProductsModel number
NACatalog number
00-1238-004-00
Lot number
NA
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A 31" OFFSET DOUBLE CLAMP BAR WAS RETURNED TO THE MFR. VISUAL INSPECTION REVEALED A BROKEN CLAMP. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS INCIDENT.
Additional Manufacturer Narrative
VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE CLAMP WAS BROKEN. THIS MDR IS BEING SUBMITTED LATE, AS IT WAS IDENTIFIED AS PART OF A RETROSPECTIVE REVIEW CONDUCTED BY ZIMMER ORTHOPEDIC SURGICAL PRODUCTS (ZIMMER OSP). THIS RETROSPECTIVE REVIEW WAS CONDUCTED IN RESPONSE TO AN INSPECTIONAL OBSERVATION AT A ZIMMER FACILITY. THE AGENCY'S INSPECTIONAL OBSERVATION CONCERNED THE COMPANY'S DECISION(S) NOT TO SUBMIT CERTAIN MDRS FOR PRODUCTS SPECIFIC TO THAT ZIMMER FACILITY. WHILE A RETROSPECTIVE REVIEW OF COMPLAINTS FOR UNREPORTED MDRS WAS CONDUCTED IMMEDIATELY FOLLOWING THE INSPECTION AT THE FACILITY, ZIMMER DETERMINED THAT SUCH A REVIEW WOULD BE CONDUCTED AT ALL ZIMMER FACILITIES. AS A RESULT, ZIMMER OSP COMPLETED ITS RETROSPECTIVE REVIEW AND IS NOW SUBMITTING THIS MDR.