MINI JOINT DISTRACTOR/COMPRESSOR
Received May 20, 2024 · Event occurred Apr 13, 2022
Report 1220246-2024-03505 · MDR key 19351154
Device
Generic name
Orthopedic Manual Surg Instr
Manufacturer
Arthrex, Inc.Model number
MINI JOINT DISTRACTOR/COMPRESSORCatalog number
AR-8970JD
Lot number
6402180804
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
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. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.
Description of Event or Problem
ON 04/13/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-8970JD MINI JOINT DISTRACTOR/COMPRESSOR WOULDN'T UNLOCK PROPERLY AFTER BEING DISTRACTED. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.