NA 357.403Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982196262), received between Jan 17, 2017 and May 12, 2025 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Break; Break

  WHILE THE SURGEON WAS REAMING THE FEMORAL SHAFT, THE REAMER GUIDE BROKE. A DIFFERENT DEVICE WAS USED. FURTHERMORE, THE YELLOW DEVICE MELTED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005511 ↗
• MalfunctionMar 7, 2025Entrapment of Device; Contamination /Decontamination Problem; Entrapment of Device; Contamination /Decontamination Problem

  THE DEVICE ARRIVED DIRTY AND FULL OF BONES. THE PIECE OF BONE FELL ON THE PATIENT. ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.

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

  MAUDE report 21549167 ↗
• InjuryMar 21, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 DURING HIP SURGERY 6.0/10.0 STEP DRILL BIT BROKE WHILE DRILLING FEMORAL HEAD. LOWERED TFN IN FEMUR WAS DONE AND PLACED HELICAL BLADE BELOW DRILL BIT FRAGMENTS. TIP OF DRILL BIT BROKE OFF IN TWO PIECES AND REMAINED IN FEMORAL HEAD. SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF 45 MINUTES. THIS COMPLAINT INVOLVES ONE(1) DEVICE 6.0/10.0 STEP DRILL BIT CANN/LRG QC/435. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13841144 ↗
• MalfunctionSep 2, 2021Corroded; Failure to Cut; Contamination /Decontamination Problem; Corroded; Failure to Cut; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STEPPED CANNULATED DRILL BIT WAS RECEIVED FROM REPACKAGED FIELD RETURNS AND WHEN SALES REPRESENTATIVE OPENED IT, IT HAD OBVIOUS WEAR MARKS ON THE CUTTING FLUTES, WATER SPOTS FROM BEING PROCESSED, AND THE BEGINNINGS OF RUST IN THE GROOVES OF THE CUTTING FLUTES. THE DEVICE WAS NOT INSPECTED CLOSELY TO BE REPACKAGED AND SOLD AS NEW. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416858 ↗
• MalfunctionJun 28, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, STEP DRILL BIT CANN/LARGE TIP WAS BROKEN OFF. IT IS UNKNOWN IF THERE ARE PROCEDURE AND PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 6.0/10.0 STEP DRILL BIT CANN/LRG QC/435. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12079580 ↗
• MalfunctionJan 27, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE TIP OF THE DRILL BIT WAS BROKEN. IT WAS UNKNOWN HOW AND WHEN IT OCCURRED. THERE WAS NO INFORMATION ABOUT PROCEDURE AND PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT INVOLVES ONE (1) 6.0MM/10.0MM STEPPED DRILL BIT, CANNULATED/LARGE QC/435MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11240403 ↗
• MalfunctionApr 30, 2020Failure to Cut; Failure to Cut

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE DRILL STOP (357.405) WASN'T LOCKING INTO THE REAMER AT THE PROPER INCREMENT. THE STEPPED CANNULATED STILL BIT REAMER (357.403) WAS ALSO DULL FROM WEAR AND TEAR. THERE WAS NO SURGICAL DELAY, FRAGMENTS OR PATIENT ISSUES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR 1 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10014846 ↗
• MalfunctionApr 16, 2020Break; Break

  IT WAS REPORTED THAT ON MARCH 24, 2020 THE STEPPED DRILL BIT CANNULATED LARGE QUICK COUPLING WAS FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968951 ↗
• MalfunctionMar 26, 2020Break; Break

  IT WAS REPORTED THAT ON FEBRUARY 27, 2020, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING REAMING AT THE RIGHT FEMUR TO COLLECT BONE GRAFT, THE REAMER HEAD BROKE. THE REAMER HEAD WAS REMOVED WITH A GUIDE WIRE BUT THERE WERE SOME FRAGMENTS RETAINED IN THE FEMUR. THERE WAS AN ATTEMPT TO SUCTION OUT THE FRAGMENTS BUT THAT FAILED. THE GUIDE WIRE WAS BENT IN AN EXTREME CURVE TO PREFERENTIALLY REAM AND COLLECT RIA GRAFT FROM DISTAL FEMUR. THE SURGEON FORCED THE RIA REAMER DOWN OVER THE BEND OF THE WIRE AND BROKE THE REAMER HEAD. FRAGMENTS OF THE REAMER HEAD WERE LEFT IN THE FEMUR. THE REAMER HEAD WAS REMOVED VIA THE BALL TIP GUIDE WIRE. DURING OPENING THE ENTRY HOLE, THE TIP OF A STEPPED CANNULATED DRILL BIT BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: GUIDE WIRE (PART# 351.706S, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9882426 ↗
• MalfunctionMar 6, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN ORTHOPEDIC PROCEDURE, THE VERY TIP OF A STEPPED CANNULATED DRILL BIT BROKE OFF INSIDE THE BONE DURING DRILLING. THE SURGEON HAD TO USE A NEW REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM AND WAS DRILLING INTO THE PROXIMAL FEMUR WITH THE DRILL BIT PROVIDED IN THE SET. THERE DID NOT APPEAR TO BE ANY DIFFICULTY DRILLING THE BONE. ADDITIONAL C-ARM IMAGES WERE TAKEN, AND THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS A THREE TO FOUR (3 TO 4) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM. THIS IS REPORT 1 OF 1 FOR (B)(4). CONCOMITANT DEVICES REPORTED: 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9799328 ↗
• MalfunctionJan 30, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, ONE (1) STEPPED DRILL BIT CANNULATED DID NOT FUNCTION; SIX (6) DEPTH GAUGE FOR LOCKING SCREWS, TWO (2) LOCKING BOLT MEASURING DEVICE, AND ONE (1) TITANIUM STERNAL LOCKING STRAIGHT PLATE WERE FOUND TO BE BROKEN DURING REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM. THIS IS REPORT 01 OF 10 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9647702 ↗
• MalfunctionNov 21, 2019Device-Device Incompatibility; Device-Device Incompatibility

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9356810 ↗
• MalfunctionOct 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE STOPPER DOES SLIP ON THE DIRT BIT. IT IS UNKNOWN THAT WHEN AND IT IS UNKNOWN WHEN THE DAMAGE OCCURRED. THERE ARE NO PATIENT CONSEQUENCES. THIS IS REPORT FOR 02 OF 02 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9202109 ↗
• MalfunctionApr 2, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGERY USING A TROCHANTERIC FEMORAL NAILING (TFN) SYSTEM ON (B)(6) 2019. DURING THE PROCEDURE, THE TIP OF AN UNKNOWN TFN REAMER SHEARED OFF INSIDE THE PATIENT. IT WAS BELIEVED THAT ON INSERTING THE REAMER IT MAY HAVE TOUCHED THE NAIL HENCE WHY THE TIP OF THE REAMER SHEARED OFF. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPETED WITH NO SURGICAL DELAY. PATIENT OUTCOME STATUS WAS UNKNOWN. CONCOMITANT DEVICE: UNKNOWN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8474581 ↗
• MalfunctionFeb 5, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A FEMORAL INTERMEDULLARY NAILING PROCEDURE ON (B)(6) 2019, THE STEPPED DRILL BIT CANNULATED BROKE. THE PART OF THE STEPPED DRILL BIT HAD SNAPPED OFF WHILE IN USE. NO OTHER INSTRUMENT WAS BEING USED AT THE SAME TIME. THERE WAS A TEN (10) MINUTE DELAY IN SURGERY AS THEY HAD TO RETRIEVE THE BROKEN PIECE OF INSTRUMENT. ALL PARTS OF THE STEPPED DRILL BIT WERE RETRIEVED. THE PATIENT SUFFERED NO HARM BECAUSE OF THIS ACCORDING TO THE SURGEON AND THE OPERATION WAS COMPLETED WITHOUT FURTHER INCIDENCE. THIS REPORT IS FOR ONE (1) 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8306805 ↗
• MalfunctionDec 26, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING PROXIMAL FEMORAL NAILING, THE TIP OF THE REAMER CANNULATED BROKE OFF IN THE PATIENT. THE TIP/SMALL PIECE WAS REMOVED WITH THE HELP OF GRAVITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THERE WAS NO PATIENT COMPLICATION AFTER THE PROCEDURE. THIS REPORT IS FOR ONE (1) 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8196106 ↗
• MalfunctionNov 30, 2018Break; Break

  IT WAS REPORTED PATIENT UNDERWENT A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE ON (B)(6) 2018. WHILE SURGEON WAS IRRIGATING THE WOUND PRIOR TO CLOSING, METAL SHAVINGS WERE NOTED TO BE PRESENT. IT WAS DETERMINED THE METAL SHAVINGS WERE FROM THE CANNULATED DRILL BIT USED DURING THE PROCEDURE. ALL FRAGMENTS WERE RETRIEVED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR ONE (1) CANNULATED DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8119166 ↗
• InjurySep 13, 2018Break; Break

  IT WAS REPORTED THAT DURING A TROCHANTERIC FIXATION NAIL SURGERY ON (B)(6) 2018, A STEPPED CANNULATED DRILL BIT WAS BROKEN WHILE DRILLING. THERE WERE TINY PIECES OF FRAGMENTS REMOVED FROM THE PATIENT BUT THERE WERE STILL SOME TINY PIECES SEEN ON X-RAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE: DRILL: (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE QC/435MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7874369 ↗
• MalfunctionJun 12, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THE REAMER BROKE DURING AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE. THIS REPORT IS FOR ONE (1) 6MM/10MM REAMER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594344 ↗
• InjuryMay 10, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THE 6.0MM/10.0MM STEPPED DRILL BIT (REAMER) FROM THE TROCHANTERIC FIXATION NAIL (TFN) SET BROKE DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018. THIS REPORT IS FOR ONE (1) 6.0MM/10.0MM STEPPED DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 7504761 ↗
• MalfunctionAug 21, 2017Break; Break

  IT WAS REPORTED THAT THE TIP OF A 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED/LARGE WITH QUICK COUPLING WAS FOUND BROKEN OFF IN CENTRAL STERILE PROCESSING. NO KNOWN PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 6.0MM/10.0MM STEPPED DRILL BIT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6807841 ↗
• MalfunctionJun 1, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE FOLLOWING: A 6.0MM/10MM STEPPED CANNULATED DRILL BIT WAS BROKEN DURING SURGERY ON (B)(6) 2017. THERE WAS NO GENERATION OF FRAGMENTS FROM BROKEN DEVICE. THERE WAS NO DELAY IN SURGERY. THERE WAS NO PATIENT HARM. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6606943 ↗
• MalfunctionJan 17, 2017Break; Break

  IT WAS REPORTED THAT THE SYNTHES 6.0MM / 10.0MM STEPPED CANNULATED DRILL BIT BROKE DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE ON (B)(6) 2016. THERE WERE NO FRAGMENTS RETAINED IN THE PATIENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6255251 ↗