NA 309.035Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982185549), received between Sep 15, 2017 and Feb 5, 2024 — classified as 1 injury, 7 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2024Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE IS BROKEN. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) HOLLOW REAMER COMPLETE FOR 3.5MM & 4.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18646472 ↗
• MalfunctionJan 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS PC IS RELATED TO (B)(4) WHICH REPORTS THAT THE CORTEX SCREW WAS BROKEN AFTER THE PRIMARY SURGERY. THIS PC REPORTS THAT THE REAMER TUBE WAS BROKEN DURING THE REVISION SURGERY. IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT THE REVISION SURGERY FOR THE PLATEAU PSEUDOARTHROSIS. THE SURGEON USED THE HOLLOW REAMER TO REMOVE THE BROKEN CORTEX SCREW IN BONE. DURING USING THE HOLLOW REAMER, THE REAMER TUBE WAS BROKEN. THE SURGEON CONFIRMED BY THE IMAGE AND DIRECT OBSERVATION AND DETERMINED THAT THERE WAS NO BROKEN BLADE IN THE BODY. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) HOLLOW-REAMER-COMPL ANTICLOCKWISE CUTTIN THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214032 ↗
• MalfunctionJul 20, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT AT AN UNKNOWN DATE IN 2022, THE REAMER WAS FOUND TO BE UNABLE TO CUT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A HOLLOW REAMER COMPLETE 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 15065612 ↗
• MalfunctionMay 21, 2021Break; Break

  THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867294 ↗
• InjuryMar 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 1 OF 2 FOR REPORT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9837169 ↗
• MalfunctionMar 3, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, THE THREADED PORTION OF A HOLLOW REAMER COMPLETE WAS BROKEN OFF INTO THE SPARE REAMER TUBE FOR HOLLOW REAMER. THE ISSUE WAS FOUND OUT IN THE STERILE PROCESSING. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 01 OF 01 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9780422 ↗
• MalfunctionFeb 8, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A HOLLOW REAMER HAD BREAKAGE OF SCREWS. IT IS UNKNOWN IF THERE WERE A PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) HOLLOW REAMER COMPLETE FOR 3.5MM & 4.0MM SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8323473 ↗
• MalfunctionSep 15, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2017, AND EXTRACTION BOLT FOR 4.5MM SCREWS BROKE AND THE THREAD OF A HOLLOW REAMER COMPLETE FOR 3.5MM & 4.0MM SCREWS IS BROKEN AND HAS A SCREW STUCK INSIDE OF IT. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. CONCOMITANT DEVICES REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HOLLOW REAMER COMPLETE FOR 3.5MM & 4.0MM SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6870514 ↗