NA 309.038Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982185556), received between Mar 9, 2017 and Apr 3, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 21763903 ↗
• MalfunctionNov 3, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, THE TREPHINE FROM THE SCREW REMOVAL SET BROKE OFF IN THE PATIENT AND PART OF IT COULD NOT BE RECOVERED. THE PART WAS LODGED IN THE PLANTER ASPECT OF THE FIRST CUNEIFORM. ANOTHER TREPHINE WAS USED TO REMOVE THE REST. THERE WERE FIFTEEN MINUTES OF SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFUL. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE SPARE REAMER TUBE FOR HOLLOW REAMER (309.035). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067228 ↗
• MalfunctionMar 16, 2023Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT REVISION SURGERY FOR PLATEAU PSEUDOARTHROSIS. THE SURGEON USED THE HOLLOW REAMER TO REMOVE A BROKEN CORTEX SCREW IN BONE. DURING USE. THE HOLLOW REAMER TUBE WAS BROKEN. THE SURGEON CONFIRMED THIS BY IMAGING AND DIRECT OBSERVATION AND DETERMINED THAT THERE WAS NO BROKEN BLADE IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT IS FOR A SPARE REAMER TUBE FOR HOLLOW REAMER (309.035). THIS IS REPORT 2 OF 2 FOR (B)(4) AND CAPTURES THE BROKEN REAMER TUBE. THE BROKEN SCREW IS CAPTURED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554735 ↗
• MalfunctionJul 27, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPAREREAMERTUBE F/309.035. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15118042 ↗
• MalfunctionJul 20, 2022No Apparent Adverse Event; No Apparent Adverse Event

  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) SPARE REAMER TUBE FOR HOLLOW REAMER THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064541 ↗
• 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 COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) SPARE REAMER TUBE FOR HOLLOW REAMER. THIS REPORT IS 3 OF 6 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11870066 ↗
• InjuryApr 6, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THAT DURING A SCREW REMOVAL TIME A TREPHINE WAS BROKE OFF. FRAGMENTS WERE GENERATED BUT IT WAS UNKNOWN IF IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT CONSEQUENCE IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9930244 ↗
• MalfunctionMar 16, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A SURGERY FOR DISTAL TIBIA WITH THE LOCKING SCREWS. ON AN UNKNOWN DATE, THE SURGEON FOUND THAT ONE SCREW HAD BEEN BROKEN. ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL SURGERY WITH THE HOLLOW REAMER DUE TO THE SCREW BREAKAGE. DURING THE SURGERY, THE SURGEON FOUND THAT THE OTHER 2-SCREWS HAD BEEN BROKEN AND HE HAD DIFFICULTY IN REMOVING THE BROKEN SCREW WITH THE HOLLOW REAMER BECAUSE THE PATIENT¿S BONE QUALITY WAS GOOD. HE TRIED MANY TIMES, AND WHEN HE PRESSURED THE REAMER AXIALLY, THE TIP OF THE REAMER BROKE. HE REMOVED THE FRAGMENT OF THE BROKEN REAMER, BUT THE FRAGMENT OF THE SCREWS REMAINED IN THE PATIENT. HE COMPLETED THE SURGERY WITH ANOTHER HOLLOW REAMER WITHIN 30 MINUTES DELAY. THE TOTAL OF THE BROKEN SCREWS IS 3. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), SPARE CENTERING PIN (PART # 309.370, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS 2 OF 2 FOR REPORT (B)(4). (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9837254 ↗
• 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) SPARE REAMER TUBE FOR HOLLOW REAMER (309.035). THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8301549 ↗
• MalfunctionAug 7, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018 IN THE STERILE PROCESSING DEPARTMENT, A SPARE REAMER TUBE AND HOLLOW REAMER WERE FOUND CONNECTED TOGETHER INCORRECTLY AND BECAME STUCK. THE TWO DEVICES WERE SEPARATED AND UPON SEPARATION IT WAS NOTICED THAT THE FLUTES ON THE SPARE REAMER TUBE HAD CHIPPED OFF AND BROKE. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7758590 ↗
• MalfunctionAug 18, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHEN THE CUSTOMER RETURNED THE SPARE REAMER TUBE TO THE LOAN DEPARTMENT, IT WAS BROKEN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6803655 ↗
• MalfunctionMar 9, 2017Break; Break

  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, Q

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6393261 ↗