3-POINT SHOULDER DISTRACTION SYSTEM
Received Jun 5, 2024 · Event occurred Aug 17, 2022
Report 1220246-2024-04935 · MDR key 19468976
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
14957702
Product problems
- Component Missing
- Component Missing
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. SEE ATTACHED FOR SUPPLIER EVALUATION. THE MOST LIKELY CAUSE OF THE FAILURE IS USE ERROR DUE TO EXCESSIVE FORCE ON THE DEVICE.
Description of Event or Problem
ON 08/17/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM IS MISSING THE ADJUSTMENT KNOB ON THE BOTTOM. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.