NA 309.069Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982185594), received between Dec 18, 2017 and Dec 29, 2025 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE SURGERY, THE SURGEON USED THE HOLLOW REAMER FOR REMOVING A SCREW. WHILE THE SURGEON REMOVING THE SCREW, A PART OF THE HOLLOW REAMER BROKE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. DURING DEVICE RETURN VISUAL INSPECTION TWO (2) ADDITIONAL DEVICES WERE FOUND TO BE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905106 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT THE EXTRACTION BOLT IS BROKEN/DAMAGED. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20206886 ↗
• MalfunctionMay 22, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE EXTRACTION BOLT WAS IDENTIFIED AS DAMAGED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THIS REPORT IS FOR AN EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373889 ↗
• MalfunctionDec 21, 2023Break; Break

  IT WAS REPORTED THAT ON 19-OCTOBER-2023 WHILE REMOVING A SCREW FROM THE PATIENT¿S RIGHT HIP, THE EXTRACTOR IN QUESTION BROKE INTO SEVERAL PIECES. ALL GENERATED FRAGMENTS WERE REMOVED WITHOUT ADDITIONAL MEDICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18371946 ↗
• MalfunctionNov 13, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED VIA FEEDBACK FROM OR STAFF THAT THE T8 DRIVER REQUIRED REPLACING DUE TO DIFFICULTY ENGAGING WITH SCREW HEADS. IT WAS ALSO REPORTED THAT OTHER ITEMS NEEDED TO BE INSPECTED DURING THE SALES REP VISIT. AFTER INSPECTION FROM THE SALES REP WAS COMPLETED, OTHER ITEMS WERE FOUND REQUIRING REPLACEMENT DUE TO THEIR BEING WORN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 7 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18123109 ↗
• MalfunctionOct 4, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, IT WAS IDENTIFIED THAT THE TIPS OF THE INSTRUMENTS HAD BEEN SNAPPED OFF. THIS WAS NOTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17869363 ↗
• MalfunctionMar 7, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REMOVAL SURGERY FOR WITH THE PRODUCTS IN QUESTION BECAUSE TWO YEARS AFTER THE INITIAL SURGERY ON DECEMBER 4, 2020, SHE SUFFERED OSTEONECROSIS AND NEEDED TO BE REPLACED WITH A THA AFTER FNS REMOVAL. IN THE EXTRACTION OF THE DISTAL 5.0 LOCKING SCREW, THE SCREW DID NOT LOOSEN AT ALL EVEN AFTER CLEANING THE INSIDE OF THE HEAD AND ATTEMPTING EXTRACTION WITH LIGHT HAMMERING OF FNS-3 AND FNS-4. THE INSERTION HANDLE WAS THEN ATTACHED TO THE PLATE AND A SIMILAR EXTRACTION ATTEMPT WAS MADE, BUT THE SCREW DID NOT LOOSEN. THE SURGEON DETERMINED THAT THE SCREW HEAD HAS BEEN STRIPPED AS THE SCREWDRIVER AND SCREW HEAD BITE HAS WEAKENED, AND MOVED TO THE EXTRACTION DRILL AND ATTEMPTED FURTHER EXTRACTION WITH THE EXTRACTION SCREW. THE EXTRACTION SCREW BIT INTO THE SCREW HEAD, BUT THE SCREW DID NOT LOOSEN, RESULTING IN BREAKAGE OF THE EXTRACTION SCREW TIP IN QUESTION. THE SCREW HEADS WERE GROUND OUT WITH A 4.0 CARBIDE DRILL AND A 6.0 CARBIDE DRILL, AND THE ANTI-ROTATION SCREW, NECK BOLT, AND PLATE WERE EXTRACTED. THE SURGEON CONTINUED FURTHER REMOVAL OF THE SCREWS REMAINING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16497262 ↗
• MalfunctionFeb 21, 2023Break; Break

  THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409079 ↗
• MalfunctionOct 19, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SWEDEN AS FOLLOWS: IT WAS REPORTED THAT ORTHOKIT HAS RECEIVED INFORMATION FROM CUSTOMER THAT PRODUCT BROKE AFTER USE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15632619 ↗
• MalfunctionJul 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT SEVERAL OF THE ELEMENTS MENTIONED WERE DAMAGED DURING THE EXTRACTION OF THE DISTAL BLOCK OF THE TFN NAIL, BECAUSE IT WAS ROLLED. ONE OF THE REAMERS BROKE AND THE OTHER WAS ANCHORED WITHOUT THE POSSIBILITY OF DISARMING TO THE EXTRACTION BOLT, THE TECHNICAL ASSISTANT TRIED SEVERAL TIMES AND COULD NOT BECAUSE OF HOW TIGHT IT WAS, THE CONCAVE GUIDE BROKE THE TIP WHEN TRYING TO REMOVE THE BONE AROUND THE SCREW. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) EXTRACT-BOLT F/SCR Ø6 6.5+7. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15128895 ↗
• MalfunctionDec 17, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A SURGERY, THE TIP OF THE BOLT BROKE. ALL THE BROKEN PART AND FRAGMENTS WERE COLLECTED. THE SURGEON STATED THAT THERE WAS AN ALLOWANCE ON THE CONNECTION BETWEEN THE HANDLE AND BOLT, AND THE FORCE WAS NOT CONVEYED WELL. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13027443 ↗
• MalfunctionAug 5, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE EXTRACTOR WAS FOUND BROKEN. IT WAS UNKNOWN WHEN AND HOW THE DAMAGE HAPPENED. THERE WAS NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12282109 ↗
• MalfunctionMar 11, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DOCTOR WAS USING EXTRACTION BOLT FROM THE BROKEN SCREW REMOVAL SET. AS THE SURGEON WAS TURNING IT COUNTERCLOCKWISE TO ATTACH IT TO THE BROKEN SCREW, A PIECE OF THE BOLT BROKE OFF. THE SURGEON OPENED ANOTHER BROKEN SCREW REMOVAL SET AND USED AN UNKNOWN 6.5/7.0 HOLLOW REAMER OUT OF IT. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9820273 ↗
• MalfunctionSep 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: UNKNOWN PLATE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1), UNKNOWN HOLLOW REAMER (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1); UNKNOWN SCREW (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9118782 ↗
• MalfunctionAug 5, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON AN UNKNOWN DATE, PART OF THE EXTRACTING THREAD HAD BROKEN OFF FROM THE MAIN BODY OF THE EXTRACT-BOLT F/SCR DIA6.5+7. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR AN EXTRACTION BOLT FOR 6.5MM & 7.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8859497 ↗
• MalfunctionApr 16, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7433281 ↗
• MalfunctionApr 16, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DEVICES WERE BROKEN. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7433255 ↗
• MalfunctionDec 18, 2017Break; Break

  IT WAS REPORTED THAT A SYNTHES EXTRACTION BOLT BROKE FROM A SYNTHES BROKEN SCREW REMOVAL SET WHILE TRYING TO REMOVE A BROKEN ZIMMER LARGE FRAGMENT 6.5 MM CANCELLOUS SCREW DURING A HARDWARE REMOVAL ON (B)(6) 2017 IN PREPARATION FOR THE PATIENT TO UNDERGO A TOTAL KNEE ARTHROPLASTY. A ZIMMER LATERAL PROXIMAL TIBIA PLATE WAS INITIALLY USED ON AN UNKNOWN DATE TWELVE (12) YEARS AGO, FOR A HIGH TIBIAL OSTEOTOMY. DURING THE REMOVAL, HEADS OF TWO (2) PROXIMAL ZIMMER 6.5 MM CANCELLOUS SCREWS BROKE OFF AND THE SURGEON USED A HOLLOW REAMER FOR 6.5 MM AND 7.0 MM SCREWS TO CLEAR OUT THE BONE AROUND THE CANCELLOUS SCREWS. AN EXTRACTION BOLT WAS THEN USED ON THE ANTERIOR SCREW AND WHILE TURNING IT COUNTERCLOCKWISE, THE EXTRACTION BOLT BROKE AT THE WAISTED PORTION. THIS CAUSED A TWENTY TO THIRTY (20-30) MINUTES OF SURGICAL DELAY TO REMOVE THE BROKEN PORTION OF THE EXTRACTION BOLT. ALL OTHER SCREWS AND THE PLATE WERE REMOVED WITHOUT ANY COMPLICATIONS. NO FLUOROSCOPY WAS USED DURING THE HARDWARE REMOVAL AND CLINICALLY, IT APPEARED THAT NO FRAGMENTS OF THE BROKEN BOLT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING PLIERS FROM THE BROKEN SCREW REMOVAL SET. THE PATIENT IS REP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7126608 ↗