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. "PER CUSTOMER DEVICE WILL NOT BE RETURNED. PER (B)(4), SERVICE ENTITLEMENT NOT EXECUTED. " THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER-APPLIED EXCESSIVE MECHANICAL FORCES.

Description of Event or Problem

ON 03/18/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1600M LIMB POSITIONER IS BROKEN, THE CABLE SNAPPED ON THE WEIGHT HOLDER. THIS OCCURRED DURING AN UNKNOWN CASE WITH NO PATIENT EFFECT REPORTED.