NA 309.290Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982185716), received between Dec 19, 2018 and May 5, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Material Twisted/Bent

  WEAR WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084834 ↗
• MalfunctionJul 28, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY WITH THE EXTRACT-BOLT. THE EXTRACTION BOLT WAS PREPARED FOR THE REMOVAL OF THE VA OLECRANON PLATE. THE 2.7 MM VA LOCKING SCREW WAS DIFFICULT TO REMOVE, AND ONLY THE SCREW SHAFT WAS EMBEDDED IN THE BONE. AN EXTRACTION BOLT WAS USED TO ATTEMPT REMOVAL, BUT THE SCREW SHAFT COULD NOT BE GRASPED. ONE SCREW REMAINED IN THE BONE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636130 ↗
• MalfunctionJul 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON JULY 3, 2024 DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN IT WAS IDENTIFIED THAT THE EXTRACT BOLT IS BLOCKED. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 2.7MM SCREWS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19831688 ↗
• MalfunctionAug 15, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL HUMERUS FRACTURE. ON (B)(6) 2023, THE BONE-UNION ACHIEVED, THE PATIENT UNDERWENT SURGERY TO REMOVE A DHP DOUBLE PLATE. THE 2.7 SCREWS COULD NOT BE REMOVED WITH SCREWDRIVER, AND FIVE SCREWS WERE BROKEN WITH A CARBIDE DRILL. THE SURGEON THEN ATTEMPTED TO REMOVE THE SCREWS WITH THE EXTRACTION BOLT, BUT IT STRIPPED. THE SCREWS COULDN'T REMOVE EVEN WITH HOSPITAL-OWNED PLIERS. AT THE SURGEON'S DISCRETION, THE SURGERY WAS COMPLETED WITH FIVE SCREWS REMAINING IN THE PATIENT'S BODY. REGARDING THE CAUSE OF SCREWS BREAKAGE, THE SURGEON MENTIONED THAT THE STRESS COULD HAVE BEEN CONCENTRATED. THE SURGERY WAS COMPLETED SUCCESSFULLY MORE THAN 60 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXTRACT-BOLT F/SCR Ø2.7 THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552338 ↗
• MalfunctionMay 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY FOR CALCANEUS WITH THE VA- CALCANEAL. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, REMOVAL SURGERY WAS PERFORMED ON AN UNKNOWN DATE. DURING THE REMOVAL, IT WAS CONFIRMED, THAT THE LOCKING SCREW 2.7 IN QUESTION HAD BROKEN UNDER THE HEAD. THE SURGEON TRIED EXTRACTION BY THE EXTRACTION BOLT IN QUESTION WITH A HOLLOW REAMER, BUT THE EXTRACTION BOLT IDLED WITHOUT MATCH ON THREAD. THE LOCKING SCREW WAS PULLED OUT USING A VISE GRIP BY DIGGING A LITTLE DEEPER IN FRONT BONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES OF SURGICAL DELAY. THE SURGEON REQUESTED, THAT THE THREADS INSIDE THE EXTRACTION BOLT BE CHECKED FOR INTEGRITY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 2.7MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16845250 ↗
• MalfunctionMar 20, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SCREW WAS DIFFICULT TO REMOVE. THIS REPORT INVOLVES ONE EXTRACTION BOLT FOR 2.7MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16573771 ↗
• MalfunctionDec 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE TCP IMPLANTS. IN THE REVISION SURGERY, THE 2.7MM LOCKING SCREW BROKE DURING REMOVAL. WHEN REMOVING THE BROKEN LOCKING SCREW REMAINING IN THE BONE, THE SURGEON SCRAPED AROUND THE LOCKING SCREW WITH THE 2.7MM HOLLOW REAMER AND USED THE 2.7MM EXTRACTION BOLT, BUT THE BOLT AND THE LOCKING SCREW DID NOT ENGAGE WELL. EVENTUALLY, THE BROKEN LOCKING SCREW WAS REMOVED. THE SURGERY WAS COMPLETED WITHIN 30 MINUTES DELAY. THE PATIENT CONDITION WAS STABLE. ON (B)(6) 2020, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY TREATING DISTAL RADIUS WITH TCP IMPLANTS. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) EXTRACTION BOLT FOR 2.7MM CORTEX SCREWS. THIS REPORT IS 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002583 ↗
• MalfunctionDec 31, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT CAPTURES THE EVENT THAT HAPPENED INTRAOPERATIVELY WHEREIN EXTRACTION BOLT COULD NOT REMOVE THE BROKEN CORTEX SCREW BODY FROM THE BONE MATRIX AND THE OTHER EXTRACTION BOLT THAT SHEARED THE REMOVED PROXIMAL PART OF THE SCREW AND BECAME DEFECTIVE WILE RELATED COMPLAINT (B)(4) FOR THE EVENT WHEREIN THE CORTEX SCREW BROKE POST-OPERATIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536001 ↗
• MalfunctionOct 15, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT INSTRUMENTS WERE FOUND BROKEN IN INSPECTION TIME. THERE IS NO PATIENT CONSEQUENCES. THIS IS REPORT FOR 4 OF 09 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192455 ↗
• MalfunctionDec 19, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, A CANNULATED SCREW PARTIALLY THREADED BROKE UPON INSERTION INTO THE BONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. DEVICE WAS RECEIVED BY MANUFACTURER WITH THREE EXTRACTION BOLTS THAT WERE USED TO REMOVE THE BROKEN CANNULATED SCREW AND MAY HAVE FRAGMENTS OF THE SCREW IN THEM. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8180189 ↗