3-POINT SHOULDER DISTRACTION SYSTEM

Additional Manufacturer Narrative

THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023.  ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. THE REPORTED EVENT IS CONFIRMED. THE MANUFACTURERS EVALUATION REVEALED THAT THE ROPE IS DEFECTIVE WHICH CAUSED THE REPORTED EVENT. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE DUE TO USER ERROR OF THE DEVICE DUE TO EXCESSIVE FORCE BEING APPLIED DURING USE.

Description of Event or Problem

IT WAS REPORTED THAT THE WIRE ROPE SNAPPED AT THE MIDDLE BAR. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.