MINI JOINT DISTRACTOR/COMPRESSOR
Received Jun 13, 2024 · Event occurred Oct 12, 2022
Report 1220246-2024-05659 · MDR key 19527008
Device
Generic name
Orthopedic Manual Surg Instr
Manufacturer
Arthrex, Inc.Model number
MINI JOINT DISTRACTOR/COMPRESSORCatalog number
AR-8970JD
Lot number
6402180808
Product problems
- Mechanical Jam
- Mechanical Jam
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 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 10/13/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-8970JD MINI JOINT DISTRACTOR/COMPRESSOR BECAME JAMMED. THIS OCCURRED DURING AN UNKNOWN CASE ON (B)(6) 2022, THE CASE CONTINUED, WITH NO PATIENT EFFECT REPORTED.