NA 309.520Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886982185822), received between Mar 9, 2017 and Feb 5, 2026 — classified as 2 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (19 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2026Material Twisted/Bent

  IT WAS REPORTED INTRA-OPERATIVELY, A DRILL BIT BROKE. WHILE TRYING TO RETRIEVE THE BROKEN DRILL BIT, THE HOLLOW REAMER BROKE. ANOTHER DRILL BIT WAS USED TO REDRILL SUCCESSFULLY. A 6.5MM RECON SCREW GOT STUCK AFTER TAPPING MULTIPLE TIMES. WHILE TRYING TO REMOVE THE STUCK SCREW, A SCREWDRIVER WAS DAMAGED. AN EXTRACTION SCREW ALSO STRIPPED DURING THE SURGERY. THE SURGEON WAS NOT ABLE TO IMPLANT THE RECON SCREW SO CHANGED TO THE SURGICAL PLAN TO ACCOMMODATE TRANSVERSE LOCKING ONLY. THE PROCEDURE WAS COMPLETED WITH A ONE-HUNDRED TWENTY (120) MINUTE DELAY.

  Patient problems: Insufficient Information

  MAUDE report 24272564 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT FROM THE BROKEN SCREW REMOVAL SET WAS BROKEN DURING USE. THERE WERE NO REPORTED PATIENT PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23826728 ↗
• MalfunctionJun 19, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE SURGERY THE SCREWING INSTRUMENT ARE BROKEN. AN EXTRACTION SCREW WAS INSERTED DURING THE OPERATION, AND IS BROKEN. SURGERY WAS CARRIED OUT SUCCESSFULLY. THERE WAS NO PATIENT HARM OR SURGICAL DELAY. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567513 ↗
• MalfunctionMay 22, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON APRIL 26, 2024, DURING LOAN KIT INSPECTION THE FOLLOWING PRODUCTS WERE IDENTIFIED AS DAMAGED: SPARE REAMER TUBE HAS A SCREW STUCK INSIDE THE CANNULATION. EXTRACTION SCREW HAS A SCREW STUCK ON THE THREADS. SPARE CENTERING PIN IS BENT AT THE TOP. EXTRACTION BOLT HAS BURRED THREADS INSIDE. THIS REPORT INVOLVES ONE (1) CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370271 ↗
• MalfunctionMar 27, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 13-MARCH-2024 DURING LOAN KIT INSPECTION, THE INSTRUMENT IN QUESTION WAS FOUND TO BE DAMAGED. THE THREADS OF THE DEVICE WERE BURRED. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986286 ↗
• MalfunctionFeb 15, 2024Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE LCP-DT IMPLANTS AT AN UNKNOWN HOSPITAL. AFTER THE SURGERY, SOFT TISSUE INJURY OCCURRED, AND A REMOVAL SURGERY WAS PERFORMED ON (B)(6) 2024. DURING THE REMOVAL SURGERY PERFORMED ON (B)(6) 2024, RECESS OF THE 2 LOCKING SCREWS BECAME STRIPPED. ONE OF THEM WAS REMOVED USING THE EXTRACTION SCREW, AND THE EXTRACTION SCREW BROKE OFF WHEN IT WAS USED FOR REMOVING THE OTHER LOCKING SCREW. THE TIP OF THE BROKEN EXTRACTION SCREW REMAINED IN THE RECESS OF THE LOCKING SCREW. SINCE THE TIP OF THE BROKEN EXTRACTION SCREW COULD NOT BE REMOVED FROM THE RECESS, THE SURGEON TRIED TO EXCAVATE THE SCREW HEAD BY THE CARBIDE DRILL BITS. HOWEVER, THE SHAFT OF THE CARBIDE DRILL BITS WAS BLURRED, AND THE SCREW HEAD COULD NOT BE EXCAVATED. THE SURGEON JUDGED THAT IT WAS IMPOSSIBLE TO EXCAVATE, AND THE SCREW WAS REMOVED WITH THE PLATE AFTER SHAVING THE BONE AROUND THE SCREW AND INSERTING A CHISEL BETWEEN THE BONE AND THE PLATE REPEATEDLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 90 MINUTES DELAY. THE ORIGINAL SCHEDULED SURGERY TIME WAS 50 MINUTES. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18716980 ↗
• MalfunctionJan 19, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, DURING LOAN KIT INSPECTION IT WAS NOTICED THAT THE TIP OF THE INSTRUMENT HAD SNAPPED OFF. THIS REPORT INVOLVES ONE (1) CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18543920 ↗
• MalfunctionNov 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, CONNICLE SCREW EXTRACTOR NOT CONNECTING TO Q/C HANDLE. THE SURGERY WAS DELAYED FOR 5 MINUTES. A DIFFERENT CONNICAL SCREW EXXTRACTOR WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) EXTRACT-SCREW CONI F/SCR Ø2.7 3.5+4. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18195010 ↗
• MalfunctionJan 25, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES BROKE DURING USE IN A SURGICAL PROCEDURE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241581 ↗
• MalfunctionJan 25, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN ITALY AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES BROKE DURING USE IN A SURGICAL PROCEDURE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 2 OF 3 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241580 ↗
• MalfunctionNov 21, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DISTRACTOR WAS FATIGUED AT THE TIME OF SURGERY ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838517 ↗
• MalfunctionNov 17, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING REMOVAL OF A SCREW, THE PART FRACTURED. IT HAD NO NEGATIVE IMPLICATIONS FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15816410 ↗
• MalfunctionNov 16, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN ORTHOPEDIC PROCEDURE ON (B)(6) 2022, THE INSTRUMENTS HAD WORN TIPS AND DID NOT HAVE GOOD GRIPS ON THE SCREWS. THIS INCIDENT HAD PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804149 ↗
• MalfunctionAug 31, 2022Break; Break

  DEVICE REPORT FROM AUSTRIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE EXTRACTION SCREW IN QUESTION BROKE DURING SCREW EXTRACTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information; Unspecified Tissue Injury

  MAUDE report 15326961 ↗
• MalfunctionMay 12, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, WHILE EXTRACTING A COLD WELDED 3.5 MM LOCKING HEAD SCREW FROM PHILOS PLATE, THE CONICAL EXTRACTION SCREW DID NOT WORK. CARBIDE DRILL WAS USED TO TAKE OFF THE SCREW HEAD AND THEN PLATE COULD BE REMOVED. THE REMAINING SCREW SHAFT WAS OVERDRILLED AND DRILL INTRAMEDULLARY DISRUPTED. ALL FRAGMENTS OF THE INSTRUMENT COULD BE REMOVED. THERE WAS A FIFTEEN (15) MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14379864 ↗
• MalfunctionDec 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE CONICAL EXTRACTOR WAS BROKEN WHILE ATTEMPTING TO REMOVE A NON-SYNTHES DISTAL HUMERUS PLATE. NO INFORMATION WAS PROVIDED ON THE EXACT SURGERY DATE, PATIENT, OR LOT NUMBER. IT WAS NOTED THAT FRAGMENTS WERE GENERATED. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12987051 ↗
• MalfunctionJun 25, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE CONICAL EXTRACTION BOLT WAS SNAPPED DURING THE USE. NO PATIENT CONSEQUENCES. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN CORTEX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN) THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071101 ↗
• MalfunctionSep 16, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE PARTS WERE DISCOVERED AS WORN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541595 ↗
• MalfunctionSep 2, 2020Mechanical Problem; Material Deformation; Material Twisted/Bent; Mechanical Problem; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A CONICAL EXTRACTION SCREW WAS FOUND TO BE DEFECTIVE. THE ISSUE WAS DISCOVERED DURING ROUTINE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10483929 ↗
• MalfunctionAug 3, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE BY THE LOAN KIT TECHNICIAN DURING A LOAN KIT INSPECTION THAT THE EXTRACTING END OF THE CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREW AND THE EXTRACTION BOLT FOR 2.0MM SCREWS HAVE SNAPPED OFF. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10356989 ↗
• MalfunctionMay 4, 2020Break; Break

  THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER REMOVING THE MATERIAL THE PATIENT HAD IMPLANTED. THE REMOVAL SCREW THAT WAS BROKEN WAS REPLACED WITH LFN NAIL MATERIAL TO FINISH REMOVING THE SCREW. THERE WAS NO SURGICAL CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10022254 ↗
• MalfunctionJan 6, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A FEMUR PROCEDURE ON AN UNKNOWN DATE, THE EXTRACTION SCREW BROKE. FEMUR NAIL AND HIP SCREWS HAS ALREADY BEEN IMPLANTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIFTEEN (15) MINUTES. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9553786 ↗
• MalfunctionDec 18, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN HUNGARY AS FOLLOWS: IT WAS REPORTED THAT THE HEAD OF THE SCREW BROKE. IT IS UNKNOWN WHERE AND HOW THIS ISSUE OCCURRED. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 2.7MM & 3.5MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491844 ↗
• InjuryNov 21, 2019Break; Break

  THE EXTRACTION SCREW WAS USED TO REMOVE BROKEN SCREWS.

  Patient problems: No Code Available

  MAUDE report 9354316 ↗
• MalfunctionSep 9, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2019, THE CANNULATED HEXAGONAL POWER SCREWDRIVER TO THE 6.5 MM CANNULATED SCREWS BROKE AT THE TIP DURING A PELVIS RECONSTRUCTION CASE. ALSO, THE 2.5 HEXAGONAL CONICAL EXTRACTOR WAS STRIPPED DURING THE POLY TRAUMA PROCEDURE. THERE WERE FRAGMENTS GENERATED FROM A BROKEN DEVICE. THERE WAS NO OTHER REQUIRED MEDICAL INTERVENTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN 6.5 MM CANNULATED SCREWS(PART#UNKNOWN, LOT#UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 2 FOR 2 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8974876 ↗