NA 03.010.446Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982068880), received between Oct 8, 2018 and Jun 1, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE DOCTOR USED THE EXTRACTION SCREW TO REMOVE A TIBIA NAIL AND IT DAMAGED THE THREADS SO IT NEEDS TO BE REPLACED AS IT'S CROSS-THREADED NOW. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347689 ↗
• MalfunctionDec 6, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON HAD AN ISSUE THREADING THE SUPRAPATELLAR EXTRACTION SCREW DURING THE TIBIAL NAIL REVISION. UPON INSPECTION AFTER REMOVAL IT APPEARS THAT THE THREADS WERE DAMAGED. WHEN PUTTING IN THE NEW NAIL, THE SURGEON HAD A HARD TIME FITTING THE INNER SLEEVE IN THE 12MM/8MM PROTECTION SLEEVE. ANOTHER SET WAS OPENED AND THAT ONE WORKED FINE. THERE WAS A 20 MINUTES OF SURGICAL DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO OTHER MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20870248 ↗
• MalfunctionNov 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING PREOPERATIVE INSPECTION OF A NAIL EXTRACTION SET ON (B)(6) 2023, IT WAS NOTED THAT THE EXTRACTION SCREW WAS FAULTY. THE TIP OF THE DEVICE APPEARS TO HAVE BECOME DISPLACED. THIS REPORT IS FOR A EXTRACTION SCREW/M8 FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073005 ↗
• MalfunctionSep 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS FOUND IN STERILE PROCESSING DEPARTMENT (SPD) THAT TWO (2) EXTRACTORS WERE MANGLED AND UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821832 ↗
• MalfunctionSep 26, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON SEPTEMBER 11, 2023, IT WAS FOUND IN STERILE PROCESSING DEPARTMENT (SPD) THAT TWO (2) EXTRACTORS WERE MANGLED AND UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821831 ↗
• MalfunctionSep 26, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE TWO NAIL EXTRACTORS FOUND IN STERILE PROCESSING DEPARTMENT (SPD) AREA CONNECTED TO NAILS. THE SPD SUPERVISOR PUT INTO SHARPS CONTAINER DUE TO SAFETY CONCERNS. THE SPD SUPERVISOR COULD NOT REMOVE THEM AND CLAIMED THEY WERE CROSS THREADED INTO NAIL. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821739 ↗
• MalfunctionSep 26, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE TWO NAIL EXTRACTORS FOUND IN STERILE PROCESSING DEPARTMENT (SPD) AREA CONNECTED TO NAILS. THE SPD SUPERVISOR PUT INTO SHARPS CONTAINER DUE TO SAFETY CONCERNS. THE SPD SUPERVISOR COULD NOT REMOVE THEM AND CLAIMED THEY WERE CROSS THREADED INTO NAIL. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821738 ↗
• MalfunctionJun 23, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON UNKNOWN DATE, WHILE INVENTORYING SETS IT WAS NOTICED THAT SOME INSTRUMENTS WERE AFFECTED. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192901 ↗
• MalfunctionMay 12, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THAT ON (B)(6) 2023, THE THREADS OF THE DEVICE WERE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16920037 ↗
• MalfunctionJun 22, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING CLEANING & INSPECTION THE EXTRACTION SCREW REPORTED WITH BROKEN TIP BY STERILE PROCESSING STAFF. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14779900 ↗
• MalfunctionApr 4, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF THE BACK UP DEVICES IT WAS DISCOVERED THAT THE GOLD PEG OF ONE (1) RECON LOCKING AIMING ARM FOR LFN NAILS-EX HAS SNAPPED OFF, THE THREADS OF ONE (1) EXTRACTION SCREW FOR TI FEMORAL & TIBIAL NAILS AND ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR ARE STRIPPED, AND ONE (1) DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS WAS STUCK IN PLACE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14001839 ↗
• MalfunctionFeb 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL PROCEDURE FOR AN UNKNOWN FEMORAL RECON NAIL, THE EXTRACTION SCREW WAS ATTACHED TO THE NAIL AND THEN TO THE HAMMER GUIDE. AFTER THE SURGERY, THE HAMMER GUIDE AND EXTRACTION SCREW WERE ATTACHED AND COULD NOT BE SEPARATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS SUCCESSFUL. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559867 ↗
• MalfunctionOct 1, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, THE EXTRACTION SCREW, HAND REAMER, AND SCREWDRIVER DID NOT WORK AS INTENDED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12563909 ↗
• MalfunctionFeb 3, 2021Corroded; Corroded

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION, THE EXTRACTION SCREW FOR SUPRATELLAR WAS NOTED TO BE CORRODED. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR. THIS IS REPORT 1 OF 1 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11274731 ↗
• MalfunctionDec 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2020, THE COMPRESSION DEVICE FOR SUPRAPATELLAR, EXTRACTOR, CONNECTING SCREWS AND EXTRACTION SCREW WERE STRIPPED, TROCARS WERE BENT ALONG WITH THE WIRE GUIDES, BLUE HANDLE, BLACK KNOB BROKE OFF, ALONG WITH BUTTONS ON THE SIDE TO PROTECTION SLEEVE. THE SURGEON WAS AGGRESSIVE AND OVER-TORQUED PRODUCTS LEADING TO STRIPPING AND BENDING OF PRODUCTS. A NEW SET BROUGHT INTO THE ROOM. THERE WERE 10 MINUTES OF SURGICAL DELAY. IT IS UNKNOWN IF THE SURGERY SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT 11 DEVICES. THIS REPORT IS FOR (1) EXTRACTION SCREW/M8 FOR SUPRAPATELLAR. THIS REPORT IS 3 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072163 ↗
• MalfunctionMar 29, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6), 2019, WHILE INSPECTING THE INSTRUMENTS AFTER COMING THROUGH THE WASH, IT WAS NOTICED THAT THERE WERE THREE INSTRUMENTS THAT APPEARED TO BE DAMAGED. FIRST WAS THE TIP OF THE MONOBLOC FLEXIBLE REAMER WAS BROKEN OFF, THE SECOND WAS THE THREADS ON THE TIP OF THE EXTRACTION SCREW FOR SUPRAPATELLAR WERE DAMAGED AND LASTLY THE THREAD ON THE TIP OF THE EXTRACTION SCREW FOR TITANIUM FEMORAL AND TIBIAL NAIL WERE DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. WHILE INVESTIGATING THE EXTRACTION SCREW IT WAS NOTED THE THREAD IS PLASTICALLY DEFORMED POST-MANUFACTURING. THIS REPORT IS FOR AN EXTRACTION SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8463807 ↗
• MalfunctionOct 8, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT AN EXPERT TIBIAL NAIL REMOVAL SURGERY DUE TO PAIN. DURING SURGERY, ONE (1) EXTRACTION SCREW FOR TIBIAL NAIL COULD NOT BE CONNECTED TO THE NAIL. ANOTHER ONE (1) EXTRACTION SCREW FOR SUPRAPATELLAR COULD BE ATTACHED TO THE NAIL BUT IT CAME OFF WHEN THE SURGEON USED A SLIDE HAMMER. THE SURGEON TRIED SEVERAL TIMES AND ENDED WITH THE SAME RESULT. THE SURGERY WAS FINISHED BY REMOVING ONLY THE LOCKING SCREW AND THE NAIL WAS LEFT IN THE PATIENT'S BODY. THE SURGEON STATED IT WAS NOT A PROBLEM DUE TO THE PATIENT REPORTED PAIN WHERE THE SCREW HEAD WAS LOCATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF THIRTY (30) MINUTES. THIS (B)(4) CAPTURES INTRA-OPERATIVE EVENT OCCURRED ON (B)(6) 2018. (B)(4) CAPTURES POST-OPERATIVE PAIN THAT REQUIRED REVISION SURGERY. THIS REPORT IS FOR ONE (1) EXTRACTION SCREW FOR SUPRAPATELLAR. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7943426 ↗