STANDARD WISHBONE ASSEMBLY

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

A FACILITY REPORTED THAT DURING ABDOMINAL SURGERY, THERE WAS BREAKAGE OF THE STANDARD WISHBONE ASSEMBLY (4020). IT WAS REPORTED THAT THE MEDICAL STAFF WAS ABLE TO FINISH THE PROCEDURE. THERE WAS APPROXIMATELY A 30-MINUTE INCREASE IN SURGERY TIME; HOWEVER, NO PATIENT INJURY OCCURRED.

Additional Manufacturer Narrative

FAILURE ANALYSIS: AFTER EVALUATION, THE HANDLE ASSEMBLY WAS REPLACED ALONG WITH SOME NEEDED SMALL PARTS (CAM BEARINGS, CAM BOLT, CAM BUSHING). THE NUT, WASHER AND RING WERE REPLACED FOR ROUTINE OVERHAUL. BOTH WISHBONE ARM ASSEMBLIES WERE REPLACED. THE UNIT HAS BEEN SUBJECTED TO A SUCCESSFUL FUNCTION CHECK. ROOT CAUSE ANALYSIS: BASED ON THE EVALUATION BY INTEGRA SERVICE AND REPAIR, THE ROOT CAUSE IS MOST LIKELY MISHANDLING OF THE PRODUCT LEADING TO DAMAGES. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY WAS IDENTIFIED FOR CORRECTION AS A RESULT OF THIS COMPLAINT INVESTIGATION.