EVOLVE HEAD 26MM

Additional Manufacturer Narrative

CORRECTION: PLEASE REFER H3 DEVICE EVALUATED BY MFG 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: VISUAL EXAMINATION OF THE RETURNED PRODUCT CONFIRMS THE CATALOG AND LOT NUMBER. THE PRODUCT WAS RETURNED IN AN OPENED CONDITION. THERE IS VISIBLE DAMAGE TO THE OUTER CARTON BOX INCLUDING CREASES AND SLIGHT TEARS AROUND THE EDGES OF THE BOX. THE BACK OF THE BOX IS SCRATCHED WITH PORTIONS OF THE SURFACE VISIBLY WORN AWAY. THIS DAMAGE MOST LIKELY RESULTED FROM ROUGH HANDLING DURING TRANSPORT OR STORAGE INDICATING THE OUTER PACKAGING EXPERIENCED SOME FORM OF IMPACT OR ABRASION. THE INNER STERILE PACKAGING APPEARS SIGNIFICANTLY WRINKLED AND WAS FOUND OPENED AS REPORTED. AN ATTEMPT WAS MADE TO RETRIEVE AND INSPECT A PRODUCT FROM THE SAME LOT. HOWEVER, NONE WERE FOUND IN STOCK. SINCE THE PRODUCT WAS RETURNED IN AN OPENED CONDITION, THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. 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. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

Description of Event or Problem

DEVICE HAD INCOMPLETE AND COMPROMISED STERILE PACKAGING.

Additional Manufacturer Narrative

ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

DEVICE HAD INCOMPLETE AND COMPROMISED STERILE PACKAGING.