DOUBLE CLAMP BAR

Description of Event or Problem

IT WAS REPORTED THAT A CLAMP ON THE 31" OFFSET DOUBLE CLAMP BAR BROKE AS A PT WAS ATTEMPTING TO GET OUT OF BED. 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.