Admiral AP2-100002Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10889981276775), received between May 12, 2025 and May 1, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Fracture

  ON 03 APR 2026, ORTHOFIX WAS MADE AWARE OF THE FOLLOWING EVENT UTILIZING THE SEASPINE ADMIRAL ACP SYSTEM. PER THE REPORTER, THE TIP OF THE SCREWDRIVER SHEARED OFF AND BECAME STUCK IN THE SCREW. THE FRACTURED TIP REMAINED IN THE SCREW AND COULD NOT BE REMOVED. THEY COULD ONLY PARTIALLY SLIDE THE LOCKING COVER OVER THE SCREWS. THE PATIENT WAS REPORTED TO BE UNINJURED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25058661 ↗
• MalfunctionMar 24, 2026Fracture

  ON 25 FEB 2026, ORTHOFIX WAS MADE AWARE OF MULTIPLE ADMIRAL DRIVER TIP FRACTURES. IT WAS REPORTED THAT THE FRACTURED TIPS BECAME LODGED IN THE SCREW SHANK AND WERE UNABLE TO BE RETRIEVED WITHOUT REMOVING THE ENTIRE SCREW. THIS RESULTED IN A SURGICAL DELAY OF GREATER THAN 30 MINUTES. NO PATIENT INJURIES WERE REPORTED. QUALITY COMPLIANCE MADE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THE EVENT; HOWEVER, CUSTOMER WAS UNRESPONSIVE. IT IS UNKNOWN IF THE ENTIRE SCREW WAS REPLACED OR IF THE SCREW WAS LEFT IN-SITU WITH THE UNRETRIEVED FRAGMENT. THIS REPORT IS FOR 3 OF 4 UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24683270 ↗
• MalfunctionMar 24, 2026Fracture

  ON 25 FEB 2026, ORTHOFIX WAS MADE AWARE OF MULTIPLE ADMIRAL DRIVER TIP FRACTURES. IT WAS REPORTED THAT THE FRACTURED TIPS BECAME LODGED IN THE SCREW SHANK AND WERE UNABLE TO BE RETRIEVED WITHOUT REMOVING THE ENTIRE SCREW. THIS RESULTED IN A SURGICAL DELAY OF GREATER THAN 30 MINUTES. NO PATIENT INJURIES WERE REPORTED. QUALITY COMPLIANCE MADE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THE EVENT, HOWEVER, CUSTOMER WAS UNRESPONSIVE. IT IS UNKNOWN IF THE ENTIRE SCREW WAS REPLACED OR IF THE SCREW WAS LEFT IN-SITU WITH THE UNRETRIEVED FRAGMENT. THIS REPORT IS FOR 2 OF 4 UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682948 ↗
• MalfunctionMar 24, 2026Fracture

  ON 25 FEB 2026, ORTHOFIX WAS MADE AWARE OF MULTIPLE ADMIRAL DRIVER TIP FRACTURES. IT WAS REPORTED THAT THE FRACTURED TIPS BECAME LODGED IN THE SCREW SHANK AND WERE UNABLE TO BE RETRIEVED WITHOUT REMOVING THE ENTIRE SCREW. THIS RESULTED IN A SURGICAL DELAY OF GREATER THAN 30 MINUTES. NO PATIENT INJURIES WERE REPORTED. QUALITY COMPLIANCE MADE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THE EVENT, HOWEVER, CUSTOMER WAS UNRESPONSIVE. IT IS UNKNOWN IF THE ENTIRE SCREW WAS REPLACED OR IF THE SCREW WAS LEFT IN-SITU WITH THE UNRETRIEVED FRAGMENT. THIS REPORT IS FOR 4 OF 4 UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682864 ↗
• MalfunctionMar 24, 2026Fracture

  ON (B)(6) 2026, ORTHOFIX WAS MADE AWARE OF MULTIPLE ADMIRAL DRIVER TIP FRACTURES. IT WAS REPORTED THAT THE FRACTURED TIPS BECAME LODGED IN THE SCREW SHANK AND WERE UNABLE TO BE RETRIEVED WITHOUT REMOVING THE ENTIRE SCREW. THIS RESULTED IN A SURGICAL DELAY OF GREATER THAN 30 MINUTES. NO PATIENT INJURIES WERE REPORTED. QUALITY COMPLIANCE MADE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THE EVENT, HOWEVER, CUSTOMER WAS UNRESPONSIVE. IT IS UNKNOWN IF THE ENTIRE SCREW WAS REPLACED OR IF THE SCREW WAS LEFT IN-SITU WITH THE UNRETRIEVED FRAGMENT. THIS REPORT IS FOR 1 OF 4 UNITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24677356 ↗
• MalfunctionMay 12, 2025Material Fragmentation; Material Fragmentation

  CUSTOMER REPORTS THAT DURING A SURGERY THAT TOOK PLACE ON (B)(6) 2025, THE TIP OF THE AP2-100002 ADMIRAL ACP SCREWDRIVER SHEARED OFF. ALL PIECES WERE RETRIEVED; HOWEVER, THE ISSUE RESULTED IN A 30-MINUTE SURGICAL DELAY. NO ADDITIONAL MEDICAL OR SURGICAL TREATMENT WAS REQUIRED; THE SURGERY WAS ABLE TO BE COMPLETED AND THERE WERE NO ADVERSE PATIENT OUTCOMES. CUSTOMER STATES THE SURGEON USED THE PROPER TECHNIQUE WITH THE INSTRUMENTATION. MULTIPLE FOLLOW-UP ATTEMPTS WERE PERFORMED TO HAVE THE PRODUCT RETURNED FOR INVESTIGATION, HOWEVER, THE ADMIRAL ACP SCREWDRIVERS WERE NOT RETURNED AND ARE NOT AVAILABLE FOR EVALUATION. THIS OCCURRED WITH TWO SEPARATE ADMIRAL ACP SCREWDRIVERS. THIS MDR IS TO DOCUMENT THE EVENT AGAINST ONE LOT OF THE ADMIRAL ACP SCREWDRIVERS. SEE MDR 3012120772-2025-00031 FOR THE SECOND LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007055 ↗
• MalfunctionMay 12, 2025Material Fragmentation; Material Fragmentation

  CUSTOMER REPORTS THAT DURING A SURGERY THAT TOOK PLACE ON (B)(6) 2025, THE TIP OF THE AP2-100002 ADMIRAL ACP SCREWDRIVER SHEARED OFF. ALL PIECES WERE RETRIEVED, HOWEVER, THE ISSUE RESULTED IN A 30-MINUTE SURGICAL DELAY. NO ADDITIONAL MEDICAL OR SURGICAL TREATMENT WAS REQUIRED, THE SURGERY WAS ABLE TO BE COMPLETED AND THERE WERE NO ADVERSE PATIENT OUTCOMES. CUSTOMER STATES THE SURGEON USED THE PROPER TECHNIQUE WITH THE INSTRUMENTATION. MULTIPLE FOLLOW-UP ATTEMPTS WERE PERFORMED TO HAVE THE PRODUCT RETURNED FOR INVESTIGATION, HOWEVER, THE ADMIRAL ACP SCREWDRIVERS WERE NOT RETURNED AND ARE NOT AVAILABLE FOR EVALUATION. THIS OCCURRED WITH TWO SEPARATE ADMIRAL ACP SCREWDRIVERS. THIS MDR IS TO DOCUMENT THE EVENT AGAINST THE SECOND LOT OF THE ADMIRAL ACP SCREWDRIVERS. SEE MDR 3012120772-2025-00030 FOR THE FIRST LOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22007043 ↗