MINI JOINT DISTRACTOR/COMPRESSOR

Additional Manufacturer Narrative

THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

ON 03/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06522233 THAT AN AR-8970JD MINI JOINT DISTRACTOR/COMPRESSOR FAILED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6 BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B3, B5, G3.

Description of Event or Problem

ADDITIONAL INFORMATION WAS PROVIDED ON 3/27/2024 WHERE THE SALES REPRESENTATIVE STATED THAT THIS EVENT OCCURRED DURING A FOOT & ANKLE RECONSTRUCTION ON (B)(6) 2024. THE AR-8970JD FAILED TO SWITCH BETWEEN THE COMPRESSION, NEUTRAL, AND DISTRACTOR POSITIONS. IT WOULD GET STUCK AND NEED EXCESSIVE FORCE TO SWITCH POSITIONS. THE CASE WAS COMPLETED USING A MALLET THE SWITCH WAS MOVED TO THE NECESSARY POSITION TO FINISH THE CASE.