QUAD CUTTER

Additional Manufacturer Narrative

H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. HOWEVER, AN IMAGE EVALUATION WAS PERFORMED AND FOUND THE DEVICE IN ITS OPEN PACKAGE. THE OUTER BLADE IS MISSING. 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 OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE FINDINGS CANNOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE AN IMPACT EVENT INCONSISTENT WITH NORMAL USE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT THE TIP OF THE QUAD CUTTER BROKE AND WENT MISSING. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.