MINI JOINT DISTRACTOR/COMPRESSOR
Received Nov 5, 2025 · Event occurred Oct 22, 2025
Report 1220246-2025-04999 · MDR key 23475161
Device
Generic name
Orthopedic Manual Surg Instr
Manufacturer
Arthrex, Inc.Model number
MINI JOINT DISTRACTOR/COMPRESSORCatalog number
AR-8970JD
Lot number
6402180805
Product problems
- Physical Resistance/Sticking
- Physical Resistance/Sticking
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. THE DEVICE WAS NOT RECEIVED FOR EVALUATION. 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 CONCLUDED THE MOST LIKELY CAUSE. THE MOST LIKELY CAUSE OF THE REPORTED FAILURE IS ATTRIBUTED TO USER ERROR, SUCH AS APPLYING EXCESSIVE FORCE. THE DEVICE HAS A MANUFACTURING DATE OF 2019. THE COMPLAINT ALLEGATION COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO SUPPORTING EVIDENCE OF THE REPORTED FAILURE WAS PROVIDED.
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 10/27/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8970JD MINI JOINT DISTRACTOR/COMPRESSOR HAD A WIRE COLD WELD INTO THE PIN DISTRACTOR. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.