NA 03.037.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10886982070180), received between May 31, 2019 and Aug 4, 2026 — classified as 1 death, 1 injury, 44 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50133746 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT DRILL BIT Ø16 FLEX CANN F/QUICK COUP F/D WAS BROKEN INTO TWO OR MORE PIECES DURING THE OPENING OF THE MAJOR TROCHANTER IN A PROCEDURE. THE EVENT OCCURRED INTRA-OPERATIVELY WHEN THE FLEXIBLE INITIATOR BIT WAS REMOVED, AND THE BREAKAGE WAS OBSERVED. THE SPECIALIST EXPERIENCED NO DISCOMFORT, THE DEVICE WAS NOT REQUIRED FURTHER IN THE PROCEDURE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829740 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THE TIP OF THE DRILL BIT WAS MISSING A PIECE SO THE OTHER ONE FROM THE SET WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782343 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING A STAFF NOTICED MULTIPLE ISSUES WITH DEVICES. NO WIRES ARE ABLE TO BE PASSED THROUGH THE WIRE GUIDE SLEEVES. IT SEEMS LIKE THE INNER METAL IS BURRED AND PREVENTING THE PROPER PASSAGE OF WIRES. THE TFNA INSERTION HANDLE HAS BEEN CROSS THREADED AND NO AIMING ARM IS ABLE TO BE THREADED INTO THE ATTACHMENT SLOT. NO DRILL STOPS WILL STAY LOCKED INTO THE CANNULATED STEP DRILL BITS. THERE IS ABNORMALLY LARGE SPACE BETWEEN SEGMENTS OF THE FLEXIBLE DRILL BITS WHICH CAUSES A WOBBLE WHEN USED ON POWER TO OPEN THE FEMUR FOR NAIL INSERTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286310 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING A STAFF NOTICED MULTIPLE ISSUES WITH DEVICES. NO WIRES ARE ABLE TO BE PASSED THROUGH THE WIRE GUIDE SLEEVES. IT SEEMS LIKE THE INNER METAL IS BURRED AND PREVENTING THE PROPER PASSAGE OF WIRES. THE TFNA INSERTION HANDLE HAS BEEN CROSS THREADED AND NO AIMING ARM IS ABLE TO BE THREADED INTO THE ATTACHMENT SLOT. NO DRILL STOPS WILL STAY LOCKED INTO THE CANNULATED STEP DRILL BITS. THERE IS ABNORMALLY LARGE SPACE BETWEEN SEGMENTS OF THE FLEXIBLE DRILL BITS WHICH CAUSES A WOBBLE WHEN USED ON POWER TO OPEN THE FEMUR FOR NAIL INSERTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23286025 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT DURING MEDICAL DEVICE REPROCESSING A STAFF NOTICED MULTIPLE ISSUES WITH DEVICES. NO WIRES ARE ABLE TO BE PASSED THROUGH THE WIRE GUIDE SLEEVES. IT SEEMS LIKE THE INNER METAL IS BURRED AND PREVENTING THE PROPER PASSAGE OF WIRES. THE TFNA INSERTION HANDLE HAS BEEN CROSS THREADED AND NO AIMING ARM IS ABLE TO BE THREADED INTO THE ATTACHMENT SLOT. NO DRILL STOPS WILL STAY LOCKED INTO THE CANNULATED STEP DRILL BITS. THERE IS ABNORMALLY LARGE SPACE BETWEEN SEGMENTS OF THE FLEXIBLE DRILL BITS WHICH CAUSES A WOBBLE WHEN USED ON POWER TO OPEN THE FEMUR FOR NAIL INSERTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285616 ↗
• MalfunctionJul 18, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING TROCHANTERIC FEMORAL NAIL FOR LIMB SHORTENING WITH OSTEOTOMY THE DRILL BIT WAS BLUNT. SURGEON CHANGED FROM A TFNA TO AN FRNA USING DIFFERENT INSTRUMENTS, ALTHOUGH THIS CHANGE WAS NOT FULLY FORCED BY THE BLUNT REAMER, AND MORE THE SURGEON¿S PREFERENCE. THERE WAS A 30 MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22544222 ↗
• MalfunctionJun 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  TFNA AIMING ARM AND ALL ASSOCIATED PIECES NEED TO BE REPLACED DUE TO DIFFICULTY AND ABNORMALLY HIGH RESISTANCE EXPERIENCED WHEN INSERTING GUIDE SLEEVES. THEY APPEARED TO GET JAMMED AND STUCK BEFORE FULL INSERTION WAS ACHIEVED. THIS WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320950 ↗
• MalfunctionMar 20, 2025Corroded; Corroded

  IT WAS REPORTED THAT ON FEBRUARY 3, 2025, THE 16MM CANNULATED FLEXIBLE DRILL BIT HAD RUST INSIDE THE CANNULA AND THE 16 CANN PERCUTANEOUS FLEXIBLE DRILL BIT TIP IS CHIPPED. THERE WAS NO OPERATION INVOLVED AND NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655836 ↗
• MalfunctionJan 8, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DAY BEFORE SURGERY, THE INSTRUMENT SET ARRIVED AT THE HOSPITAL. AT THE TIME OF STERILIZATION, ALL HOLLOW INSTRUMENTS (HOLLOW DRILL BITS, CROWN REAMERS, ETC.) WERE FOUND TO HAVE WATER-LIKE LIQUID RESIDUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21103352 ↗
• MalfunctionNov 15, 2024Break; Break

  IT WAS REPORTED, THAT ON (B)(6) 2024. THE FLEXIBLE REAMER (03.037.002) WAS BROKEN, DURING SURGERY. SURGERY WAS NOT DELAYED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695386 ↗
• MalfunctionSep 19, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TFNA & SYNREAM REAMERS WERE BLUNT AND REQUIRED REPAIR/REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20257677 ↗
• MalfunctionMar 5, 2024Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available; Contamination /Decontamination Problem; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT AT THE BEGINNING OF A SURGICAL PROCEDURE ON (B)(6) 2024, THE DRILL BIT FOR THE CEPHALIC COMPONENT OF THE TFNA AND THE CHANNEL OPENING DRILL BIT WERE VERIFIED TO HAVE BONE RESIDUES FROM THE PREVIOUS PROCEDURE. THE DRILL BITS WERE SENT FOR STERILIZATION IN THE RAPID CYCLE SINCE THE PATIENT WAS ALREADY ANESTHETIZED AND HAD TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE OTHER NAIL INSTRUMENTATION WHILE THE DRILL BITS WERE IN THE CYCLE, HOWEVER THE SITUATION INCREASED THE SURGICAL TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE 16MM CANNULATED FLEXIBLE DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18837664 ↗
• MalfunctionFeb 8, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT THE STEPPED REAMER FOR THE TFNA HAS A CHIP AT THE TOP. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) DRILL BIT Ø16 FLEX CANN F/QUICK COUP F/D. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18669034 ↗
• MalfunctionJan 17, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NEW ZEALAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE TFNA DRILL 16MM DIAMETER HAD A LOOSE THREAD INSIDE THE CANNULATION. THIS WAS NOTED WHEN THE DEVICE WAS PROCESSED THROUGH THE STERILE PROCESSING DEPARTMENT. THERE WAS NO IMPACT TO THE CASE. THE THREAD COULD NOT BE REMOVED THROUGH CLEANING. THIS REPORT INVOLVES ONE 16MM CANNULATED FLEXIBLE DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527987 ↗
• MalfunctionJan 2, 2024Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED INTRA-OPERATIVELY THERE WERE ISSUES WITH TWO (2) DRILL BITS. THE OPENING BIT 16 HAS NO CUT, THEREFORE IT HAS TO EXERT ENOUGH FORCE TO PASS THE DRILL BIT TO THE CHANNEL. THE CALIBRATED LONG 4.2 DRILL BIT HAS NO CUTTING, ENOUGH FORCE IS REALIZED WHEN PASSING THE CORTICALS. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18424524 ↗
• MalfunctionNov 27, 2023Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 31-OCTOBER-2023 DURING AN UNKNOWN PROCEDURE, SOME OF THE TEETH OF THE DRILL BIT IN QUESTION BROKE OFF. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 16MM CANNULATED FLEXIBLE DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209829 ↗
• MalfunctionNov 8, 2023Break; Break

  IT WAS REPORTED THAT A FLEXIBLE DRILL BIT BREAK OUT OF THE TFNA SET AT HOSPITAL ON (B)(6) 2023 WITH SURGEON. THEY NEED A REPLACEMENT FOR THIS AS SOON AS POSSIBLE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 16MM CANNULATED FLEXIBLE DRILL BIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091557 ↗
• MalfunctionAug 7, 2023Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE DRILL BIT BROKE OFF. IT WAS EXTRACTED COMPLETELY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 16MM CANNULATED FLEXIBLE DRILL BIT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476688 ↗
• MalfunctionJul 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED TWO (2) DEVICES 532.015 & 03.037.002 ARE COLD WELDED TOGETHER. THE DRILL BIT WAS STUCK IN THE COUPLING. THE MALFUNCTION WAS FOUND POST-OPERATIVELY. THIS REPORT IS FOR ONE (1) 16MM CANNULATED FLEXIBLE DRILL BIT FOR (B)(4). (B)(4) IS LINKED TO (B)(4). (B)(4), CAPTURES PRODUCT: 532.015 (PTS). (B)(4), CAPTURES PRODUCT: 03.037.002 (SYN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287721 ↗
• DeathApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN ISRAEL AS FOLLOWS: ON (B)(6) 2023, AN OPERATION TO REPAIR A FEMORAL NECK FRACTURE WAS PERFORMED IN A 75-YEAR-OLD PATIENT WITH A BACKGROUND OF LUNG CANCER AND BRAIN METASTASIS. DURING THE SURGERY, AMONG OTHER THINGS, THE TFNA SYSTEM IN HOSPITAL'S POSSESSION WAS USED, WHICH INCLUDES, AMONG OTHER THINGS, A MULTI-USE HOLLOW DRILL DEVICE SKU 03.037.002. THE USE WAS MADE IN COMBINATION WITH A GUIDE WIRE SKU 357.399 REPROCESSED. DURING THE PROCEDURE, THE GUIDE WIRE, WHICH IS INTENDED FOR THE CONDUCTION OF THE HOLLOW DRILL INTO THE MEDULLARY CANAL, IN THE PROXIMAL PART OF THE HIP (BY BEING INSERTED INTO THE PROXIMAL PART OF THE HIP IN SUCH A WAY THAT PART OF IT REMAINS OUTSIDE THE BONE), LODGED INTO THE FEMUR, INTO THE DISTAL AREA OF THE FEMUR (INTO THE CANAL). ACCORDING TO THE SURGEON, HE TRIED IN DIFFERENT WAYS AND BY DIFFERENT MEANS TO RELEASE THE GUIDE WIRE FROM THE DISTAL PART OF THE FEMUR, BUT AFTER ABOUT TWO HOURS HE WAS ASKED BY THE ANESTHESIOLOGIST TO STOP THE ATTEMPTS DUE TO THE DETERIORATION OF THE PATIENT'S CONDITION. THE PATIENT DIED ON THE OPERATING TABLE. AN AUTOPSY WAS NOT PERFORMED AFTER DEATH AND THEREFORE THE CAUSE OF DEATH

  Patient problems: Insufficient Information

  MAUDE report 16765355 ↗
• MalfunctionApr 18, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BITS IN QUESTION WERE FOUND TO BE DULL AND WERE NOT PERFORMING AS INTENDED. THEY WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 16MM CANNULATED FLEXIBLE DRILL BIT. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761520 ↗
• MalfunctionApr 18, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE DRILL BITS IN QUESTION WERE FOUND TO BE DULL AND WERE NOT PERFORMING AS INTENDED. THEY WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 16MM CANNULATED FLEXIBLE DRILL BIT. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761455 ↗
• MalfunctionApr 18, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE DRILL BITS IN QUESTION WERE FOUND TO BE DULL AND WERE NOT PERFORMING AS INTENDED. THEY WERE DEEMED TO BE NO LONGER FUNCTIONAL AND WERE SUBSEQUENTLY DISCARDED. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 16MM CANNULATED FLEXIBLE DRILL BIT. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761445 ↗
• MalfunctionMar 6, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, WHILE DRILLING THE CHANNEL THE STARTER BIT BROKE. AT THE MOMENT OF PASSING THE BIT THROUGH THE PROTECTIVE GUIDE, IT COLLAPSED FROM THE TOP PART. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A 16MM CANNULATED FLEXIBLE DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16486400 ↗