AEQ. RETRACTOR SHOULDER SYSTEM
Received Apr 15, 2025 · Event occurred Mar 17, 2025
Report 0001649390-2025-00244 · MDR key 21838642
Device
Product problems
- Material Fragmentation
- Material Deformation
- Material Fragmentation
- Material Deformation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT ITEMS FROM A PRIMARY SURGERY SHOWED HAD CHUNKS MISSING DUE TO PROLONGED USE. THESE PRODUCTS, WHICH HAVE BEEN IN USE FOR 5-7 YEARS, WILL BE RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT ITEMS FROM A PRIMARY SURGERY SHOWED HAD CHUNKS MISSING DUE TO PROLONGED USE. THESE PRODUCTS, WHICH HAVE BEEN IN USE FOR 5-7 YEARS, WILL BE RETURNED.
Additional Manufacturer Narrative
THE REPORTED EVENT COULD BE CONFIRMED SINCE THE PRODUCT WAS RETURNED FOR EVALUATION AND MATCHES THE ALLEGED FAILURE MODE. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE RETURNED DEVICE EXHIBITS SIGNS OF DEGRADATION AND DEFORMATION. THERE IS A LARGE VISIBLE DEEP GROVE AS WELL AS A SIGNIFICANT GOUGE NEAR THE TIP OF THE DEVICE. THE DEVICE ALSO EXHIBITS DISCOLORATION AND DARK SPOTS. THE CONDITION IS CONSISTENT WITH WEAR AND MULTIPLE USES OF THE DEVICE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN-RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A COMBINATION OF USER AND WEAR RELATED ISSUE. THE FAILURE WAS CAUSED DUE TO EXPOSURE TO HIGH IMPACTFUL FORCES AND FREQUENT USAGE.