NA 309.490Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982185761), received between Aug 14, 2017 and Feb 19, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionFeb 19, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, IT WAS NOTED A BROKEN SCREW WAS STUCK IN THE EXTRACTION BOLT AND COULDN¿T BE REMOVED. THERE WERE REPORTEDLY NO PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389632 ↗
• InjuryJul 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH FNS IMPLANTS. AFTER THE SURGERY, OSTEONECROSIS OF THE FEMORAL HEAD OCCURRED, AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2025. (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THE BREAKAGE OF THE JJ PRODUCT OCCURRED AT THE REVISION SURGERY, AND (B)(4) WHICH REPORTS THE BREAKAGE OF THE POLO PRODUCT OCCURRED AT THE REVISION SURGERY.

  Patient problems: Necrosis

  MAUDE report 22545881 ↗
• MalfunctionDec 20, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN APRIL 2023, THE PRODUCT WAS DAMAGED PRE-OPERATIVELY. IT WAS FURTHER REPORTED THAT THE DEVICE WAS BROKEN. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 4.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367464 ↗
• MalfunctionAug 21, 2023Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS RECEIVED AS A BLIND UNIT FROM COLOMBIA ON JANUARY 19TH. HOWEVER, IT WAS FOUND DURING THE VISUAL EXAMINATION PERFORMED ON (B)(6) 2023 THAT IT IS (UNABLE TO DISASSEMBLE, BROKEN AND FOREIGN SUBSTANCE). THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 4.5MM SCREWS THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586759 ↗
• MalfunctionAug 14, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUSTOMER ASKED FOR THE INSTRUMENT TO BE REPAIRED. THIS REPORT INVOLVES ONE (1) EXTRACTION BOLT FOR 4.5MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17539742 ↗
• MalfunctionNov 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE REMOVAL SURGERY WITH THE EXTRACTION BOLT IN QUESTION. DURING THE SURGERY, THE EXTRACTION BOLT DID NOT ATTACH TO A SCREW WELL. THE SURGEON REMOVED THE SCREW IN A DIFFERENT WAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXTRACT-BOLT F/SCR Ø4.5+5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729283 ↗
• MalfunctionJul 1, 2022Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022 THAT 1 X 399.990 REDUC-FORCEPS TOOTHED RATCH-LOCK . ISSUE: PART OF FORCEP HAS BROKEN OFF 1 X 309.490 EXTRACT-BOLT F/SCR Ø4.5+5 - ISSUE: SCREW HAS BROKEN OFF INSIDE AND IS JAMMED. NO FURTHER DETAILS PROVIDED. THIS REPORT IS FOR ONE (1) EXTRACT-BOLT F/SCR Ø4.5+5. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14886413 ↗
• MalfunctionNov 12, 2020Break; Material Deformation; Break; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING LCP PROXIMAL TIBIA PLATE REMOVAL SURGERY, THE SPARE REAMER TUBE, EXTRACTION BOLT, AND CONICAL EXTRACTION SCREW WERE BROKEN AND NONFUNCTIONAL. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING OTHER INSTRUMENTS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 4.5MM SCREWS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10831639 ↗
• MalfunctionFeb 4, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS REMOVING A 4.0 CANNULATED SCREW FOR AN UNKNOWN REASON. DURING REMOVAL THE UNKNOWN 4.0 CANNULATED SCREW BROKE. IT WAS REPORTED THAT THE FOLLOWING INSTRUMENTS "BROKE INTRAOPERATIVELY": THE CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS, SPARE REAMER TUBE FOR HOLLOW REAMER, EXTRACTION BOLT FOR 4.5 SCREWS, SPARE REAMER TUBE FOR HOLLOW REAMER, SMALL HANDLE WITH QUICK COUPLING, AND CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. SURGICAL DELAY IS UNKNOWN. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 4.5MM SCREWS. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8301579 ↗
• MalfunctionAug 14, 2017Break; Mechanical Jam; Break; Mechanical Jam

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2017, AND EXTRACTION BOLT FOR 4.5MM SCREWS BROKE AND THE THREAD OF A HOLLOW REAMER COMPLETE FOR 3.5MM & 4.0MM SCREWS IS BROKEN AND HAS A SCREW STUCK INSIDE OF IT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. CONCOMITANT DEVICES REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 4.5MM SCREWS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6792914 ↗