OFFSET DOUBLE CLAMP BAR

Description of Event or Problem

A CUSTOMER REPORTED FOUR INCIDENTS OF BROKEN CLAMPS ON THE 31" OFFSET DOUBLE CLAMP BAR. THERE WAS NO REPORT OF PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THESE INCIDENTS.

Additional Manufacturer Narrative

ONE 31" OFFSET DOUBLE CLAMP BAR WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT ONE CLAMP WAS BROKEN AT THE LOCATION OF THE HINGE. THE SECOND CLAMP AT THE OPPOSITE END OF THE BAR WAS DETERMINED TO BE BROKEN AT THE LOCATION OF THE BASE. 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.