ABC SELF-LOCKING CERVICAL SCREW 4.0X16MM

Additional Manufacturer Narrative

AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

Description of Event or Problem

COUNTRY OF COMPLAINT: JAPAN. IT WAS REPORTED THAT TWO WEEKS AFTER A SUCCESSFUL SURGICAL PROCEDURE AND THE CONDITION OF THE PATIENT WAS GOOD, HE WAS SCHEDULED FOR DISCHARGED. HOWEVER, THE SCREW WAS FOUND TO BE LOOSE IN THE POSTOPERATIVE OBSERVATION TWO MONTHS LATER. IT WAS NOT DISCOVERED HOW OR WHY THE SCREW WAS LOOSE. REVISIONS TO PREVENT INJURIES WAS COMPLETED AND THE PATIENT WAS IN CONDITION. NO INJURY REPORTED TO THE PATIENT.

Additional Manufacturer Narrative

INVESTIGATION: USED TEST AND ANALYSIS EQUIPMENT: KEYENCE VHX 600D DIGITAL MICROSCOPE. FIRST WE MADE A VISUAL INSPECTION OF THE SCREW. HERE WE FOUND NO DAMAGES OR ANY INDICATIONS OF A MALFUNCTION. IN THE NEXT STEP WE CHECKED THE FREE MOVEMENT OF THE LOCKING PIN. EVEN THE LOCKING PIN WORKS PROPERLY. BATCH HISTORY REVIEW: THE MANUFACTURING DOCUMENTS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO SPECIFICATION VALID DURING THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONAL: WITHOUT FURTHER KNOWLEDGE ABOUT THE CIRCUMSTANCES, WE ASSUME, THAT THE SCREW WAS NOT PROPERLY LOCKED AFTER INSERTION. THE SCREW ITSELF WAS WITHOUT FUNCTIONAL RELEVANT DEFECTS. NO CAPA IS NECESSARY.