3-POINT SHOULDER DISTRACTION SYSTEM
Received Mar 28, 2024 · Event occurred Mar 11, 2024
Report 1220246-2024-01685 · MDR key 18994716
Device
Generic name
Traction Apparatus
Manufacturer
Arthrex, Inc.Model number
3-POINT SHOULDER DISTRACTION SYSTEMCatalog number
AR-1600M
Lot number
UNK
Product problems
- Break
- Break
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. THE COMPLAINT ALLEGATION IS CONFIRMED. BASED ON THE IMAGE PROVIDED FROM THE FIELD, IT IS EVIDENT THAT THAT THE WIRE BROKE. CONSEQUENTLY, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.
Description of Event or Problem
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REP. VIA EMAIL THAT FOR AN AR-1600M, 3-POINT SHOULDER DISTRACTION SYSTEM, THE LATERAL SHOULDER TRACTION UNIT BROKE AS THE WIRE HAD SNAPPED. THIS WAS DETECTED DURING USE IN A SHOULDER ARTHROSCOPIC STABILIZATION PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SPARE TRACTION UNIT AT THE HOSPITAL.
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.