AHTB UNIVERSAL HIP DISTRACTOR

Additional Manufacturer Narrative

THE REPORTED DEVICE, INTENDED FOR USE IN TREATMENT, WAS RECEIVED FOR EVALUATION AND FORWARDED TO THE SUPPLIER FOR ADDITIONAL INVESTIGATION. AN ANALYSIS OF THE CUSTOMER PROVIDED IMAGES NOTED A UNIVERSAL HIP DISTRACTOR LABEL WITH REF 72203270 AND S/N: (B)(6) AND A WORN BALL JOINT. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. THE PRODUCT EVALUATION CONFIRMED THE REPORTED FAILURE. THE BALL JOINT WAS DAMAGED AND THERE WAS LOW ABDUCTION FORCE. THE KNOB SPACER, 4 LOBE KNOBS, BELLOWS, AND THE THRUST BEARINGS REQUIRED REPLACEMENT. BASED ON THE SERIAL NUMBER OF THIS DEVICE, THE RECORDS SHOW THAT IT WAS MANUFACTURED IN MARCH 2016. THE COMPLAINT WAS CONFIRMED. THE ITEMS IDENTIFIED AS NEEDING REPLACEMENT OR REPAIR, HAVE BEEN DETERMINED TO BE FROM NORMAL WEAR AND TEAR THAT IS THE RESULT OF FREQUENT USE DURING THIS ITEMS SERVICE LIFE. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, THE BALL JOINT IN THE "UNIVERSAL HIP DISTRACTOR" COULD NOT HOLD THE BOOT/LEG IN POSITION. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.