NA 309.039Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982185563), received between Oct 31, 2017 and Sep 18, 2026 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50830256 ↗
• MalfunctionApr 3, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A REMOVAL SURGERY WITH THE EXTRACTION BOLT AND THE REAMER TUBE. DURING THE SURGERY, THE DEVICES BROKE. THE SURGEON REMOVED THE FRAGMENTS AS MUCH AS POSSIBLE; HOWEVER, SOME SMALL PIECES REMAINED. THE SURGEON DECIDED TO CLOSE THE WOUND. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21763902 ↗
• MalfunctionDec 2, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE USAGE OF A SYNTHES SCREW REMOVAL SET DURING THE CASE. THE INSTRUMENT BROKE APART INSIDE THE PATIENT DURING USE. PIECES OF THE INSTRUMENT WERE SUCCESSFULLY RETRIEVED. NO KNOWN HARM AT THIS TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819024 ↗
• MalfunctionNov 18, 2024

  SYNTHES SCREW REMOVAL SET USED DURING THE CASE. THE INSTRUMENT BROKE APART INSIDE THE PATIENT DURING USE. PIECES OF THE INSTRUMENT WERE SUCCESSFULLY RETRIEVED. NO KNOWN HARM AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705824 ↗
• MalfunctionMay 22, 2024Material Twisted/Bent; Material Twisted/Bent

  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) EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370085 ↗
• MalfunctionNov 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT BEFORE SURGERY, THE DRILL BITS WERE IDENTIFIED AS DYSFUNCTIONAL BY A STAFF MEMBER; NO CASE WAS IMPACTED. DEVICE INTERACTION ISSUES, FELT A GRINDING WHEN BIT WAS PASSED THROUGH GUIDE. THERE WERE NO PATIENT OUTCOMES OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138915 ↗
• MalfunctionAug 31, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT REMOVAL SURGERY WITH THE EXTRACTION BOLT. REMOVAL SURGERY WAS PERFORMED AS BONE FUSION WAS ACHIEVED. DURING THE SURGERY, THERE WAS A DEFECT WITH THE EXTRACTION BOLT. THE SCREW COULD NOT BE ATTACHED BECAUSE THE THREADING OF THE EXTRACTION BOLT DID NOT ENGAGE WITH THE THREADING OF THE SCREW SHAFT. THE SURGEON SHAVED AROUND THE SHAFT TO THE SCREW TIP AND DIRECTLY REMOVED THE SCREW. THERE ARE NO PIECES IN THE PATIENT. THE SURGEON CONFIRMED BY X-RAY AND ALL PLATES AND SCREWS WERE REMOVED. THERE WAS AN EXTENSION OF SURGERY TIME WITHIN 30 MINUTES. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE INNER THREADS OF THE DEVICE FROM THE DISTAL TIP ARE STRIPPED, THE OVERALL DEVICE HAS A WORN APPEARANCE. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17665864 ↗
• MalfunctionJul 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE CUSTOMER BOUGHT AN EXTRACTION BOLT, AND THE FIRST TIME THAT THEY USED IT DURING SURGERY ON AN UNKNOWN DATE, A SCREW GOT STUCK AND WAS UNABLE TO BE REMOVED. THIS REPORT INVOLVES ONE EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17315799 ↗
• MalfunctionMay 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, SURGEON WAS REMOVING A BROKEN PLATES AND SCREWS FROM A FOREARM AND A SCREW BECAME STUCK INSIDE OF A CONICAL EXTRACTOR. THE SURGEON WAS ABLE TO USE A DIFFERENT DEVICE AND CONTINUED TO COMPLETE THE HARDWARE REMOVAL SUCCESSFULLY. THE PLATE HAD SYNTHES SIMILARITIES SUCH AS COMBI HOLES, HOWEVER IT WAS NOT A SYNTHES PLATE BASED ON THE LETTER MARKINGS ON THE PLATE. THERE WAS A SURGICAL DELAY OF 5MINUTES. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATES (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16973382 ↗
• MalfunctionJan 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT IS DIFFICULT TO REMOVE FROM SCREW. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) EXTRACT-BOLT F/SCR Ø3.5+4. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16131075 ↗
• MalfunctionJan 3, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE ATTEMPTING TO EXTRACT A BROKEN SCREW, THE SCREW REMOVAL COMPONENTS WERE UNSUCCESSFUL AT REMOVING IT. TO THE REPORTER¿S KNOWLEDGE, THE SCREW BROKE WHILE ATTEMPTING TO REMOVE IT ¿ AN AUDIBLE SNAP WAS HEARD. THE THREADS OF AN EXTRACTOR WERE DAMAGED, POSSIBLY BEFORE THE CASE, AND DID NOT ALLOW THE HOLLOW REAMER TO THREAD COMPLETELY ON; HOWEVER, THE SURGEON USED THE PRODUCT BECAUSE IT WAS THE ONLY ONE AVAILABLE. THROUGH VARIOUS TECHNIQUES, THE SURGEON WAS FINALLY ABLE TO REMOVE THE SCREW. THE SURGERY WAS DELAYED BY 15 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087047 ↗
• MalfunctionAug 17, 2022Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE EXTRACTION BOLT IN QUESTION WAS FOUND BROKEN. PATIENT CONSEQUENCE AND PROCEDURE INVOLVEMENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15243643 ↗
• MalfunctionMay 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED: UNABLE TO REMOVE SCREW. ISSUE AN UNREPAIRABLE LETTER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) EXTRACT-BOLT F/SCR Ø3.5+4. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428727 ↗
• 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) EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541589 ↗
• MalfunctionFeb 25, 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 THAT THE SCREW WAS FOUND BENT AND JAMMED. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 01 OF 01 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752132 ↗
• MalfunctionSep 6, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8972017 ↗
• MalfunctionJul 2, 2019Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) T-HANDLE WITH QUICK COUPLING BROKE AND WON'T DETACH THE EXTRACTION BOLT. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS REPORT IS FOR A EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8752800 ↗
• MalfunctionJun 25, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2019, A NEWLY OPENED PACKAGE OF EXTRACTION BOLT FOR SCREW WAS DISCOVERED BY THE NURSE AS DAMAGED. IT WAS UNKNOWN WHERE THE ISSUE DISCOVERED. SURGICAL PROCEDURE AND PATIENT INVOLVEMENT WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8731624 ↗
• InjuryMay 23, 2019Break; Break

  UPDATED EVENT DESCRIPTION: CONCOMITANT DEVICE REPORTED: UNKNOWN PROXIMAL TIBIA PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: No Code Available

  MAUDE report 8636579 ↗
• MalfunctionDec 19, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON AN UNKNOWN DATE, A CANNULATED SCREW PARTIALLY THREADED BROKE UPON INSERTION INTO THE BONE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. DEVICE WAS RECEIVED BY MANUFACTURER WITH THREE EXTRACTION BOLTS THAT WERE USED TO REMOVE THE BROKEN CANNULATED SCREW AND MAY HAVE FRAGMENTS OF THE SCREW IN THEM. THIS REPORT IS FOR ONE (1) EXTRACTION BOLT. THIS REPORT IS 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8180187 ↗
• InjuryOct 31, 2017Break; Break

  IT WAS REPORTED THAT INITIALLY A PATIENT UNDERWENT A PLACEMENT OF A MEDIAL MALLEOLAR SCREW FOR AN ANKLE VALGUS ON AN UNKNOWN DATE TO CORRECT A DEFORMITY. A HARDWARE REMOVAL WAS SCHEDULED ON (B)(6) 2017 DUE TO THE DEFORMITY HEALING. DURING THE REMOVAL, A 4.0MM CANNULATED SCREW STRIPPED. AS THE SURGEON WAS REMOVING THE SCREW FROM THE MEDIAL MALLEOUS, THE SCREW HEAD STRIPPED. THE SURGEON USED PLIERS TO BACK THE SCREW OUT. THE HEAD THEN BROKE OFF, SO THE SURGEON USED A TREPHINE TO OPEN AROUND THE SHAFT OF THE SCREW. THE TREPHINE THEN BROKE OFF INSIDE THE PATIENT. THE SURGICAL TEAM THEN USED A CONICAL EXTRACTOR TO REMOVE THE SCREW SHAFT. THE SCREW THEN BROKE OFF INSIDE THE PATIENT. USING THE HARDWARE REMOVAL TOOLS TO EXTRACT THE SCREW, THE SURGERY WAS ABLE TO BE COMPLETED WITH THE REMOVAL OF THE ENTIRE SCREW. THERE WAS ABOUT A TEN (10) MINUTE SURGICAL DELAY. THE PATIENT STATUS IS GOOD. CONCOMITANT DEVICES REPORTED: PLIERS (PART # UNKNOWN, LOT # UNKNOWN, QTY 1), CONICAL EXTRACTOR (PART # UNKNOWN, LOT # UNKNOWN, QTY 1); HARDWARE REMOVAL TOOLS (PART # AND LOT # UNKNOWN, QUANTITY UNKNOWN) THIS REPORT IS FOR ONE (1) EXTRACTION BOLT FOR 3.5MM & 4.0MM SCREWS THIS IS REPORT 4 OF 4 FOR COMPLAINT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6991485 ↗