DISTRACTOR FOR 11MM ROD

Additional Manufacturer Narrative

OCCUPATION: REPORTER IS A SYNTHES EMPLOYEE. PART:SD393.640, SYNTHES LOT: 20P0884, SUPPLIER LOT: N/A, RELEASE TO WAREHOUSE DATE: MAY 19, 2020, EXPIRATION DATE: N/A, SUPPLIER: JABIL MONUMENT, NO RELEVANT NON-CONFORMANCES WERE NOTED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE DISTRACTOR FOR 11 MM ROD WAS RETURNED AND RECEIVED AT US CUSTOMER QUALITY (CQ). UPON VISUAL INSPECTION, THE DISTAL THREADED TIP OF THE DISTRACTOR BODY COMPONENT (SD393.640.1) WAS BROKEN AND THE BROKEN FRAGMENTS WERE NOT RETURNED. THE REMAINING THREADS OF THE DISTRACTOR BODY WERE OBSERVED TO BE DEFORMED. THERE WERE SCRATCHES AND NICKS ON THE DEVICE BUT HAVE NO IMPACT ON THE DEVICE FUNCTIONALITY. NO OTHER ISSUES WERE IDENTIFIED WITH THE RETURNED COMPONENTS OF THE DEVICE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION OF THE THREAD WAS UNABLE TO BE PERFORMED DUE TO THE DEFORMITY OF THE THREADED FEATURE BUT THE LENGTH OF THE DISTRACTOR BODY WAS MEASURED TO BE NOT WITHIN THE SPECIFICATION PER DRAWING BECAUSE OF THE DAMAGE. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE, THE CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED. DISTRACTOR FOR 11 MM ROD, BODY ASSEMBLY, DISTRACTOR BODY, NO RELEVANT NON-CONFORMANCES WERE NOTED. INVESTIGATION CONCLUSION: THE COMPLAINT CONDITION WAS CONFIRMED FOR THE DISTRACTOR FOR 11 MM ROD. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STERILE PROCESSING DEPARTMENT (SPD) GAVE A DISTRACTOR TUBE WITH A BROKEN BOLT. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR A DISTRACTOR FOR 11 MM ROD. THIS IS REPORT 1 OF 1 FOR (B)(4).