NA 309.068Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886982185587), received between Jan 13, 2017 and Feb 10, 2026 — classified as 4 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Break” (29 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Break; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SPAREREAMERTUBE F/309.065 FRACTURED INTO TWO PIECES AND WAS CLOGGED WITH BONE DURING A PROCEDURE. THE DEVICE COULD NOT BE REMOVED, BUT THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY IMPACT OR CONSEQUENCE TO THE PATIENT, AND THERE WERE NO ALTERATIONS IN SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304403 ↗
• 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 23905079 ↗
• MalfunctionOct 15, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT HARDWARE REMOVAL ON (B)(6) 2024. TWO SCREWS WERE BEING REMOVED FROM THE LEFT TIBIA. ONE OF THE REAMER TUBE CUTTING TEETH BROKE OFF IN THE PATIENT AND REMAINED IN THE OPERATIVE SITE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20451869 ↗
• MalfunctionFeb 28, 2024Break; Break

  THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS AND OUTCOME IS REPORTED AS STABLE. NO FRAGMENTS WERE PRESERVED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18802790 ↗
• MalfunctionJan 31, 2024Failure to Cut; Failure to Cut

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 15-JANUARY-2024, THE PRODUCT IN QUESTION WAS FOUND WITH WEAR AND TEAR. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SPARE REAMER TUBE FOR HOLLOW REAMER (309.065). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18612896 ↗
• MalfunctionJun 21, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE. WHILE REVIEWING SETS, THE SALES REPRESENTATIVE NOTICED, AN ISSUE WITH THE INSTRUMENTS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER (309.065). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171570 ↗
• MalfunctionApr 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REAMER WAS FOUND BROKEN SPARE REAMER TUBE. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782009 ↗
• MalfunctionJul 29, 2022Break; Break

  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) SPAREREAMERTUBE F/309.065. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15128904 ↗
• MalfunctionDec 13, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SPARE REAMER TUBE WAS BROKEN. THE ISSUE WAS FOUND AT THE BEGINNING OF THE SURGICAL INSTRUMENT CHECK. THERE WAS NO PATIENT INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER (309.065). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984019 ↗
• MalfunctionNov 3, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION ON AN UNKNOWN DATE, A LARGE PIECE OF THE CUTTING TEETH AREA OF THE SPAREREAMERTUBE F/309.065 BROKE OFF. THIS REPORT IS FOR A SPARE REAMER TUBE FOR HOLLOW REAMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12747337 ↗
• MalfunctionAug 20, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, IN STERILE PROCESSING DEPARTMENT (SPD) FOUND SEVERAL BROKEN ITEMS THAT WAS USED IN A CASE YESTERDAY. ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER WAS GRINDED UP AND BROKEN, ONE 2.7/3.5MM DEPTH GAUGE AND ONE (1) SCREWDRIVER FOR 4.5MM TITANIUM MULTILOC SCREWS WERE DAMAGED. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) SPARE REAMER TUBE FOR HOLLOW REAMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10434066 ↗
• MalfunctionFeb 7, 2020Break; Break

  CONCOMITANT DEVICE REPORTED: UNKNOWN CARBIDE DRILL (PART #: UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN PLATE (PART #: UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9684671 ↗
• MalfunctionDec 23, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED TWO REAMER TUBES WERE BROKEN. IT IS UNKNOWN WHEN THE MALFUNCTION OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9511617 ↗
• MalfunctionDec 18, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PIECE OF THE SPARE REAMER TUBE BROKE OFF. IT IS UNKNOWN WHERE AND HOW THE ISSUE OCCURRED. THIS REPORT IS FOR ONE (1) SPARE REAMER TUBE FOR HOLLOW REAMER (309.065). THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9491890 ↗
• MalfunctionNov 11, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SPARE REAMER TUBE WAS BROKEN. NO PATIENT INVOLVED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9306396 ↗
• MalfunctionNov 8, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING LEFT TOTAL KNEE ARTHROSCOPY, WHILE TRYING TO GET A SCREW OUT OF THE DEVICE THAT WAS USED TO TAKE OUT A PREVIOUS SCREW, IT BROKE INTO A FEW PIECES. THE DEVICE WAS HARD TO USE. FRAGMENTS WERE REMOVED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO HARM TO THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN DRILL BITS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). UNK - CENTERING PIN: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). UNKNOWN FLEXIBLE SHAFTS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9298511 ↗
• MalfunctionOct 18, 2019Break

  WHILE TRYING TO GET A SCREW OUT OF THE DEVICE THAT WAS USED TO TAKE OUT A PREVIOUS SCREW, IT BROKE INTO A FEW PIECES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9207338 ↗
• MalfunctionJul 19, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF SYNTHETIC MATERIAL + IMPLANTE TECNIMED (ROD). DURING THE PROCEDURE, WHILE THE DOCTOR WAS REMOVING THE SCREW HEAD THAT NO LONGER ACCEPTS THE KEY WITH THE AID OF THE SPARE REAMER TUBE, THE TIP OF THE SPARE REAMER TUBE BROKE. FRAGMENTS WERE GENERATED FROM THE BROKEN DEVICE BUT WERE REMOVED WITH NO ADDITIONAL INTERVENTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808049 ↗
• InjuryJun 6, 2019Break; Entrapment of Device; Break; Entrapment of Device

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

  Patient problems: Foreign Body In Patient

  MAUDE report 8675683 ↗
• MalfunctionMay 7, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A SPARE REAMER TUBE FOR HOLLOW REAMER WAS FOUND BROKEN DURING DECONTAMINATION. THERE WERE NO PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) SPARE REAMER TUBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8586618 ↗
• MalfunctionMar 1, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING DECONTAMINATION, A SPARE REAMER TUBE FOR HOLLOW REAMER AND AN EXTRACTION BOLT WERE FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) SPARE REAMER TUBE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8384072 ↗
• MalfunctionJan 10, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: RECEIVED A COMPLAINT OF BROKEN HOLLOW REAMER CAT. NO.-309.068 FROM (B)(6) MEDICAL COLLEGE. THE INSTRUMENT IS BROKEN AT THE CUTTING EDGE. INSTRUMENT BROKE INTRA OP. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8237873 ↗
• InjuryOct 15, 2018Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT A HARDWARE REMOVAL OF AN UNKNOWN BROKEN DEVICE. AS PER SURGEON, IT WAS MORE OF A RISK TO TAKE THE BROKEN DEVICE OUT SO IT WAS LEFT IN THE PATIENT. THE UNKNOWN SCREW THEY WERE IN THE PROCESS OF REMOVING WAS REMOVED SUCCESSFULLY. THE REAMER THAT BROKE IS A ONE TIME USE ITEM PLACED IN THE BROKEN SCREW REMOVAL SET AND PROCESSED IN STERILE PROCESSING DEPARTMENT. THE SHUKLA MEDICAL SCREW REMOVAL SET WAS THE ONE THEY ORIGINALLY WANTED BUT HAD A HOLE IN THE BLUE WRAP. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7967463 ↗
• MalfunctionAug 13, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE DURING CLEANING PROCEDURE THE DEVICE WAS FOUND BROKEN. NO PATIENT CONSEQUENCE. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7778185 ↗
• MalfunctionJun 29, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING 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 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 A SPARE REAMER TUBE FOR HOLLOW REAMER. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7650029 ↗