3-POINT SHOULDER DISTRACTION SYSTEM
Received May 30, 2024 · Event occurred May 11, 2022
Report 1220246-2024-04462 · MDR key 19430916
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
13822862
Product problems
- Positioning Failure
- Positioning Failure
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 FORM FOR INVESTIGATION.
Description of Event or Problem
ON 05/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM WAS BROKEN, WAS NOT DISTRACTING. A PIECE WAS STICKING OUT AND THE DEVICE WOULD NOT STAY UPRIGHT, THEY HAD TO HOLD ONTO IT DURING AN UNSPECIFIED PROCEDURE. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.