3-POINT SHOULDER DISTRACTION SYSTEM

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, G3, H1, H6. IT WAS REPORTED THAT THE BLACK SCREW IS DEFECTIVE. THE SUPPLIER EVALUATION REVEALED DAMAGES AT THE ROPES, END CAP AND CLAMPING LEVER. THE MOST LIKELY CAUSE IS ATTRIBUTED TO DAMAGES FROM REPEATED USE / WEAR AND TEAR. CORRECTIONS: H.1 SET AS N/A. ARTHREX PREVIOUSLY SUBMITTED THIS EVENT AS A REPORTABLE MALFUNCTION OUT OF AN ABUNDANCE OF CAUTION. UPON RECEIVING ADDITIONAL INFORMATION FROM THE FIELD THAT CLARIFIED THE EVENT AND EVALUATION OF THE RETURNED DEVICES, IT HAS BEEN DETERMINED THAT THIS EVENT DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT UNDER 21 CFR 803.

Description of Event or Problem

IT WAS REPORTED THAT THE BLACK SCREW IS DEFECTIVE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. ALSO THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.