QUAD CUTTER

Additional Manufacturer Narrative

H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT IT IS NOT IN ITS ORIGINAL PACKAGING. THE DEVICE WAS RETURNED WITH THE OUTER BLADE ASSEMBLY FRACTURED AWAY, IT WAS NOT RETURNED WITH THE HAND PIECE. THE DEVICE SHOWS WEAR FROM USE AND THE WELD LINES ON THE DISTAL END OF THE SHAFT ARE ROUGH AND PITTED. THE SPRING ON THE SAFETY STOP IS DEFORMED. A FUNCTIONAL ASSESSMENT OF THE DEVICE FOUND SINCE THE OUTER BLADE ASSEMBLY IS FRACTURED AWAY THE DEVICE CANNOT ACTUATE AS INTENDED. THE SAFETY STOP IS NO LONGER FUNCTIONAL. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE HAS BEEN ASSOCIATED WITH UNINTENDED USE OF THE DEVICE. FACTORS THAT COULD HAVE CONTRIBUTED TO THE FAILURE INCLUDE AN APPLICATION OF UNINTENDED INAPPROPRIATE OR EXCESSIVE FORCE TO THE DEVICE, ATTEMPTED CORRECTION OF A DAMAGED DEVICE, OR AN IMPACT EVENT INCONSISTENT WITH NORMAL USE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

Description of Event or Problem

IT WAS REPORTED THAT, AFTER AN ACL RECON, THE QUADCUTTER'S TIP FELL OFF, THE PART THAT HOLDS THE HEAD/CUTTER ON THE SHAFT WAS WEAK. AS THIS WAS NOTICED AFTER THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

H10: INTERNAL COMPLAINT REFERENCE: (B)(4).