AESCULAP FD330RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04038653160396), received between Feb 17, 2022 and Feb 17, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2022Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG 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 9610612-2022-00032) 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549387 ↗
• InjuryFeb 17, 2022Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG 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 BROKE OFF. THE TIP WAS RETRIEVED, AND THE PROCEDURE WAS CONTINUED. A SECOND NERVE HOOK INSTRUMENT (REF. MDR ID (B)(4)) 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 SUCCESSF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549385 ↗
• InjuryFeb 17, 2022Break; Break

  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 US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549381 ↗
• InjuryFeb 17, 2022Break; Break

  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 BROKE OFF. THE TIP WAS RETRIEVED, AND THE PROCEDURE WAS CONTINUED. A SECOND NERVE HOOK INSTRUMENT (REF. MDR ID 2916714-2022-00007) 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 US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549373 ↗