MINI JOINT DISTRACTOR/COMPRESSOR

Additional Manufacturer Narrative

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

Description of Event or Problem

ON 01/06/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8970JD MINI JOINT DISTRACTOR/COMPRESSORS SWITCH TO FLIP THE DISTRACTOR FROM COMPRESSION-NEUTRAL-DISTRACTION POSITIONS, IS DIFFICULT TO ENGAGE. THIS OCCURRED DURING A CASE AND CAUSE NO HARM ON THE PATIENT.

Additional Manufacturer Narrative

COMPLAINT ALLEGATION IS CONFIRMED. VISUAL EVALUATION NOTED THAT THE KNOB HAS AN ABRASION MARK ON THE TOP OF THE THREE EDGES. THE PART HAS DISCOLORATION ON THE ARM RACK OF THE MINI JOINT DISTRACTOR/COMPRESSOR. FUNCTIONAL TESTING WAS PERFORMED THE KNOB WAS FOUND THAT FLIPPED EASILY AND DID NOT SEAT ON THE NEUTRAL POSITION. THE MOST LIKELY REASON FOR THE REPORTED FAILURE IS THE WEAR AND TEAR DAMAGE INCURRED OVER REPEATED USAGE IN THE FIELD. MANUFACTURING DATE 2020.