MINI JOINT DISTRACTOR
Received Oct 24, 2024 · Event occurred Oct 11, 2024
Report 1220246-2024-08243 · MDR key 20524556
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
MINI JOINT DISTRACTORCatalog number
AR-8950JD
Lot number
121246
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 10/11/2024, A SALES REPRESENTATIVE VIA(B)(4) REPORTED THAT AN AR-8950JD MINI JOINT DISTRACTOR WAS BROKEN, AND NO FURTHER INFORMATION WAS PROVIDED. NO ADVERSE EFFECTS FOR THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-8950JD BATCH 121246 WAS RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, IT WAS NOTED THAT THE DEVICE HAD SIGNIFICANT SIGNS OF WEAR: FADING LASER MARKS AND MATERIAL DEGRADATION. FUNCTIONAL TESTING NOTED THAT THE LOCKING LEVER WAS LOOSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR. THE MANUFACTURING DATE IS 2013.