NA 309.510Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982185815), received between Mar 9, 2017 and Aug 20, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY WITH THE FIBULINK REMOVAL KIT. IN (B)(6) 2024, A TIBIOFIBULAR FIXATION WAS PERFORMED USING THE FIBULINK. ON (B)(6), 2025, A REMOVAL SURGERY WAS PERFORMED USING THE FIBULINK REMOVAL KIT, BUT THE NAIL COULD NOT BE COMPLETELY REMOVED. (ONLY THE TIBIAL SCREW REMAINED INSIDE THE BODY.) AFTER REMOVING THE TENSIONING CAP, AN ATTEMPT WAS MADE TO REMOVE THE TIBIAL SCREW USING A TIBIAL SCREWDRIVER, BUT THE PLACEMENT BETWEEN THE TIBIA AND FIBULA OF THE FIBULA LINK WAS NOT IN A STRAIGHT LINE AND WAS DIFFERENT IN THE ANTERIOR-POSTERIOR DIRECTION OF THE MEDIAL/LATERAL, MAKING IT IMPOSSIBLE TO CAPTURE THE TIBIAL SCREW THROUGH THE FIBULA LINK. AFTER TWISTING OFF THE PERMACORD AND REMOVING THE FIBULA LINK, THE SURGEON ATTEMPTED TO REMOVE IT USING A TIBIAL SCREW REMOVER, BUT IT DID NOT ENGAGE WITH THE TIBIAL SCREW. WHEN THE SURGEON ATTEMPTED TO REMOVE IT USING AN EXTRACTION SCREW 1.5/2.0MM, THE OUTER PART OF THE TIBIAL SCREW (THE PART THAT CONNECTS TO THE TIBIAL SCREWDRIVER) BROKE, MAKING IT COMPLETELY DIFFICULT TO REMOVE, SO THE SURGERY WAS COMPLETED WITH ONLY THE TIBIAL SCREW REMAINING INSIDE THE BODY WITHIN 30 MINUTES OF DELAY. NO FURTHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851524 ↗
• MalfunctionMay 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING INSPECTION IN STERILE PROCESSING ON APRIL 14, 2024, THAT ITEMS ARE STUCK TOGETHER AND THEY ARE NOT ABLE TO SEPARATE THEM. UNKNOWN HOW THE ITEMS BECAME STUCK. IT APPEARS AS THOUGH THE CONICAL EXTRACTOR BECAME LODGED IN THE T-HANDLE BEARINGS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271092 ↗
• MalfunctionJan 25, 2024Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON JANUARY 11 2024, THE PRODUCT DAMAGE DOCUMENTED HAD BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED. THIS REPORT IS FOR ONE (1) EXTRACT-SCREW CONI F/SCR Ø1.5+2 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18580469 ↗
• MalfunctionJan 30, 2023Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE THE SURGEON WAS ATTEMPTING TO REMOVE THE SCREWS FROM AN UNKNOWN DISTAL RADIUS PLATE AND USED A CONICAL EXTRACTOR TO TRY TO REMOVE. THE TIP OF THE CONICAL EXTRACTOR BROKE OFF INTO THE HEAD OF THE SCREW. THE FRAGMENT WAS REMOVED AND THE SURGEON PROCEEDED TO REMOVE THE DISTAL RADIUS BY OTHER METHODS SUCH AS USING A METAL CUTTING BURR TO REMOVE SCREW HEADS. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENTS WERE GENERATED AND WERE REMOVED BY ADDITIONAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16263272 ↗
• MalfunctionFeb 23, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE CONICAL EXTRACTION SCREW WAS NOTICED BROKEN DURING AN AUDIT. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE CONICAL XTRCTION SCR 1.5&2.0 CORTEX SCRS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585769 ↗
• MalfunctionMay 24, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A HARDWARE REMOVAL OF AN UNKNOWN PROXIMAL FEMUR PLATING CONSTRUCT, A COUPLE OF UNKNOWN SCREW REMOVAL EXTRACTORS WERE BROKEN AND DAMAGED. ALL BROKEN PIECES WERE SUCCESSFULLY REMOVED. THERE WAS UNKNOWN SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR (1) CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS. THIS REPORT IS 4 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870348 ↗
• MalfunctionOct 6, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10636670 ↗
• MalfunctionOct 6, 2020Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10636665 ↗
• 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 1.5MM & 2.0MM CORTEX SCREWS. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9554065 ↗
• MalfunctionDec 18, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS BROKE. IT IS UNKNOWN WHERE AND HOW THE ISSUE OCCURRED. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491967 ↗
• 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) CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS. THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8301535 ↗
• MalfunctionJan 16, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, A CONICAL EXTRACTION SCREW WAS DAMAGED DURING REMOVAL OF A CANNULATED SCREW. WHILE THE DOCTOR WAS USING THE CONICAL EXTRACTION SCREW, THE MATERIAL LOST ITS THREAD. THE DOCTOR HAD ALREADY TRIED TO REMOVE THE SCREW IN ANOTHER PROCEDURE, BUT WAS NOT ABLE TO DO SO. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES: CANNULATED SCREW (PRODUCT: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4) AND CAPTURES THE INTRAOPERATIVE EVENT. THE CAUSE OF THE REVISION SURGERY, THE PATIENT¿S DISCOMFORT, IS CAPTURED UNDER (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8255202 ↗
• MalfunctionAug 7, 2018Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE DECONTAMINATION PROCEDURE, FOUR (4) DEVICES WERE DISCOVERED TO BE NOT FUNCTIONING. ON A CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS, THE THREAD WAS DAMAGED. TWO (2) INSTANCES OF CONICAL EXTRACTION SCREWS FOR 3.5MM SCREWS WERE BROKEN. A SPARE REAMER TUBE FOR HOLLOW REAMER WAS ALSO BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7757724 ↗
• MalfunctionMar 9, 2017Break; Material Fragmentation; Dull, Blunt; Break; Material Fragmentation; Dull, Blunt

  IT WAS REPORTED THAT DURING A HARDWARE REMOVAL PROCEDURE OF A PLATE AND ONE (1) BROKEN SCREW ON (B)(6) 2017, THE SPARE REAMER TUBE FOR THE HOLLOW REAMER BROKE, THE CONICAL EXTRACTION SCREW FOR 1.5MM AND 2.0MM CORTEX SCREWS STRIPPED, AND THE CONICAL EXTRACTION SCREW FOR 2.7MM AND 3.5MM CORTEX SCREWS STRIPPED DURING REMOVAL OF THE BROKEN SCREW. FRAGMENTS GENERATED BY THE BROKEN SCREW UPON REMOVAL. IT IS UNKNOWN IF THERE WAS ANY DELAY IN SURGERY AND THE PATIENT OUTCOME IS UNKNOWN, IT IS UNKNOWN IF THE PATIENT WAS REVISED WITH ANY NEW HARDWARE. ANTICIPATED ROUTINE X-RAYS WERE TAKEN. THE UNKNOWN PLATE AND UNKNOWN QUANTITY OF UNKNOWN SCREWS, INCLUDING THE ONE (1) SCREW THAT REPORTEDLY BROKE POSTOPERATIVELY, WERE NOT CONFIRMED TO HAVE BEEN MANUFACTURED BY SYNTHES. THE MANUFACTURER IS UNKNOWN AT THIS TIME. THE DATE OF IMPLANT IS UNKNOWN. THIS COMPLAINT ADDRESSES THE SYNTHES INSTRUMENTS THAT REPORTEDLY MALFUNCTIONED DURING THE HARDWARE REMOVAL PROCEDURE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THE IMPLANTS, THIS COMPLAINT WILL BE UPDATED AND REPORTED AS NECESSARY. CONCOMITANT DEVICES REPORTED: PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1) SCREW (PART # UNKNOWN, LOT # UNKNOWN, QU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6393192 ↗