3-POINT SHOULDER DISTRACTION SYSTEM

Description of Event or Problem

ON 05/04/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1600M SHOULDER DISTRACTION SYSTEM BAR LATCHES DO NOT FIXATE. THIS OCCURRED DURING A CASE, WITH NO PATIENT EFFECT REPORTED. THE CASE WAS COMPLETED USING ANOTHER SYSTEM THAT WORKED ACCORDINGLY.

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. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, A PHYSICAL EVALUATION OF THE DEVICE WAS NOT PERFORMED. HOWEVER, THE COMPLAINT ALLEGATION IS NOT CONFIRMED WITHOUT THE DEVICE BEING RETURNED OR ANY PHOTOS PROVIDED. THE MOST LIKELY CAUSE OF THIS FAILURE IS ATTRIBUTED TO WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE. MANF. 2007.