3-POINT SHOULDER DISTRACTION SYSTEM
Received Jun 10, 2024 · Event occurred May 14, 2024
Report 1220246-2024-05454 · MDR key 19501876
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Product problems
- Material Frayed
- Material Frayed
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON 05/14/2024, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS-06567605 THAT AN AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEMS CABLING WAS FRAYING. THIS WAS DISCOVERED DURING A CASE WITH NO EFFECT ON THE PATIENT.
Additional Manufacturer Narrative
THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
COMPLAINT ALLEGATION IS CONFIRMED. ONE UNPACKAGED AR-1600M 3-POINT SHOULDER DISTRACTION SYSTEM SN: (B)(6) WAS RECEIVED FOR INVESTIGATION. VISUAL EVALUATION OF THE DEVICE NOTED SIGNIFICANT WEAR AND TEAR, THE CABLING OF THE DEVICE WAS FRAYING AND THE DEVICE HAD SCRATCHES AND SCRUFFS THROUGHOUT. FUNCTIONAL TESTING WAS UNABLE TO BE PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR - DATE OF MANUFACTURE: 2008.