MICRO HOOK SEMI SHARP STR.230MM

Additional Manufacturer Narrative

USER FACILITY MDR ID (B)(4). MANUFACTURING SITE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION OF THE UNIT WAS PERFORMED AND NO PARTS WERE RETURNED FOR FAILURE ANALYSIS. THEREFORE, THE INVESTIGATION WAS NOT ABLE TO CONFIRM A DEVICE ISSUE THAT COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE DEVICE HISTORY RECORDS (DHR) WERE NOT ABLE TO BE REVIEWED AS THE LOT NUMBER WAS NOT MADE AVAILABLE. HOWEVER, ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO DOCUMENTED PROCEDURES AND A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

Description of Event or Problem

IT WAS REPORTED TO AESCULAP INC. THAT TWO MICRO HOOK SEMI SHARP STR.230MM (PART # FD330R) WERE USED DURING AN ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF A NERVE HOOK INSTRUMENT (REF. MDR ID 2916714-2022-00006) BROKE OFF. THE TIP WAS RETRIEVED, AND THE PROCEDURE WAS CONTINUED. A SECOND NERVE HOOK INSTRUMENT WAS USED, BUT THE SAME ISSUE RECURRED; THE TIP BROKE OFF. ALTHOUGH THE TIP OF THE FIRST DEVICE WAS ABLE TO BE RETRIEVED, THE SECOND TIP WAS NOT ABLE TO BE LOCATED. X-RAYS WERE PERFORMED, BUT THE TIP WAS NOT IDENTIFIED. THE COMPLAINT DEVICES HAVE NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ADDITIONAL INFORMATION WAS PROVIDED WHICH REVEALED THE FOLLOWING, "THE TIP BROKE TWICE IN THE SAME CASE, DURING THE PART OF THE SURGERY WHERE THE LIGAMENT IS LIFTED (STANDARD TECHNIQUE), PRIOR TO REACHING THE DURA. THE FIRST TIME IT BROKE, THE FRAGMENT WAS RETRIEVED. THE SECOND TIME, IT WAS NOT RETRIEVED, POSSIBLY REMOVED BY THE SUCTION DEVICE. NO KERRISON WAS INVOLVED IN THE BREAKAGE, THE HOOKS BROKE UNDER TENSION DURING A STANDARD SURGICAL STEP. A DIFFERENT TYPE OF NERVE HOOK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT'S WAS REPORTED TO BE "DOING WELL" AFTER SURGERY. A SURGICAL DELAY OF FIFTEEN (15) TO TWENTY (20) MINUTES WAS NOTED. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER (B)(4). ASSOCIATED MEDWATCH-REPORTS: 2916714-2022-00006 ((B)(4) + FD330R): FIRST BREAKAGE.