NA 351.27Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10886982193797), received between Jul 28, 2017 and Aug 22, 2024 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (12 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SHORT ENTRY REAMERS ON MULTIPLE TRAYS ARE BLUNT AND NOT ABLE TO DRILL THROUGH BONE ANYMORE. THE LONG ONES ON THE TRAYS HAD BEEN USED, BUT THOSE ARE NOT IDEAL FOR RETROGRADE APPROACH. THIS REPORT INVOLVES ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20024475 ↗
• MalfunctionAug 21, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SHORT ENTRY REAMERS ON MULTIPLE TRAYS ARE BLUNT AND NOT ABLE TO DRILL THROUGH BONE ANYMORE. THE LONG ONES ON THE TRAYS HAD BEEN USED, BUT THOSE ARE NOT IDEAL FOR RETROGRADE APPROACH. THIS REPORT INVOLVES ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20015195 ↗
• MalfunctionAug 21, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SHORT ENTRY REAMERS ON MULTIPLE TRAYS ARE BLUNT AND NOT ABLE TO DRILL THROUGH BONE ANYMORE. THE LONG ONES ON THE TRAYS HAD BEEN USED, BUT THOSE ARE NOT IDEAL FOR RETROGRADE APPROACH. THIS REPORT INVOLVES ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20009694 ↗
• MalfunctionJul 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE GUIDE WIRE WAS EMBEDDED WITH THE CANNULATED DRILL BIT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19732161 ↗
• MalfunctionJul 9, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, IT WAS DETERMINED THAT BOTH THE 13MMM FLEXIBLE AND RIGID OPENING DRILL BITS WERE DULL AND REQUIRED REPLACEMENT. NO FRAGMENTS WERE GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19706201 ↗
• MalfunctionDec 13, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE SURGEON DISCOVERED THAT THE DRILL BIT IN QUESTION WAS VERY DULL DURING INITIAL IMPLANT REAMING AND REAMING THE LATERAL CORTEX. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT AND NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18317999 ↗
• MalfunctionNov 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE SURGEON REPORTED THAT THE DRILL BIT WAS BINDING INSIDE THE PROTECTION SLEEVE WHILE PREPARING FOR A SPIRAL BLADE WHILE USING THE RETROGRADE/ANTEGRADE FEMORAL NAIL INSTRUMENTS. THE POSITIVE STOP FEATURE BETWEEN THE SLEEVE AND DRILL BIT WAS WORN, CAUSING THE DRILL BIT TO PASS TOO DEEP INTO THE SLEEVE AND CAUSING THE BIT TO BIND WITHIN THE SLEEVE. AS A RESULT OF THE BINDING, THE DRILL BIT AND SLEEVE BECAME HOT, RESULTING IN A MINOR THERMAL INJURY TO THE PATIENT¿S SKIN. THE INSTRUMENTS WERE REMOVED FROM THE SET AND DISCARDED. THE INSTRUMENTS REQUIRE REPLACEMENT. THERE WERE PATIENT OUTCOMES AND CONSEQUENCES. THERE WAS A THERMAL INJURY TO THE PATIENT'S SKIN. THIS REPORT IS FOR ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Burn(s)

  MAUDE report 18204387 ↗
• MalfunctionNov 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT UPON INSPECTION FOLLOWING A PROCEDURE ON OCTOBER 31, 2023, STAFF NOTED THAT A DRILL BIT WAS BINDING INSIDE A PROTECTION SLEEVE. PROCEDURE HAD BEEN COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187156 ↗
• MalfunctionJul 24, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE CASE, "DRILL BIT WAS NOT SHARP ENOUGH TO ADVANCE IN THE BONE SO WE USED THE OTHER ONE IN THE SET. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS GENERATED." THIS REPORT IS FOR ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17379598 ↗
• MalfunctionJul 6, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DRILL BIT REFERENCED DID NOT CUT. THE GUIDE REFERENCED WAS BENT AND THE OTHER IS WORN. THIS REPORT IS FOR ONE (1) 13.0MM CANNULATED DRILL BIT 300MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266626 ↗
• MalfunctionMar 21, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ENTRY REAMER WAS WORN. IT WAS STRUGGLING TO DRILL THROUGH THE BONE. AN ALTERNATIVE REAMER WAS USED FOR THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583768 ↗
• MalfunctionSep 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE 13.0MM CANNULATED DRILL BIT ¿SHOULDERS¿ COULD PASS THE AUTOMATIC STOP POSITION AND ENTER INTO THE 15.0MM/13.0MM PROTECTION SLEEVE. THE REAMER WOULD GO THROUGH THE SLEEVE ANOTHER 10MM OR SO. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THIRTY SECOND DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348222 ↗
• MalfunctionApr 6, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE FOUR (4) 13MM DRILL BITS FROM THE RAFN SETS ARE DULL AND REQUIRE SHARPENING. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14027308 ↗
• MalfunctionApr 6, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE FOUR (4) 13MM DRILL BITS FROM THE RAFN SETS ARE DULL AND REQUIRE SHARPENING. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14027098 ↗
• MalfunctionDec 2, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS LYNDHURST, NJ SITE, IT WAS OBSERVED THAT THE 13.0MM CANNULATED DRILL BIT 300MM WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 13.0MM CANNULATED DRILL BIT 300MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919226 ↗
• MalfunctionOct 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE A DRILL BIT BECAME STUCK ON THE GUIDE AND COULD NOT ADVANCE. THE PATIENT WAS NOT AFFECTED. A FEW MINUTES WERE TAKEN TO SWITCH TO AN ALTERNATIVE DRILL BIT. THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUES. THIS REPORT IS FOR ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632327 ↗
• MalfunctionMar 4, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE DRILL SLEEVE TOP HAT BROKE, RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) ENTRY REAMER IS DULL, DRIVE ADAPTOR WITH QC FOR 5.0MM SCHANZ SCREWS AND DRIVE ADAPTOR WITH QC FOR 6.0 SCHANZ SCREWS WERE STRIPPED. THE PERCUTANEOUS DEPTH GAUGE, DEPTH GAUGE FOR LOCKING SCREWS, AND DEPTH GAUGE FOR CORTEX SCREWS WERE BENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THIS REPORT INVOLVES ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 3 OF 8 FOR (B)(4). THIS PRODUCT COMPLAINT, (B)(4), IS RELATED TO (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11413023 ↗
• MalfunctionJan 12, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A FEMORAL NAILING PROCEDURE, THE 13MM DRILL BIT WOULD NOT CUT. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THERE WAS NO CONSEQUENCE TO THE PATIENT. THIS REPORT INVOLVES ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156243 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE DISTAL FEMUR WITH RETROGRADE FEMORAL NAIL (RAFN) ON (B)(6) 2020, THE 13.0MM CANNULATED DRILL BIT WAS BROKEN AT THE CONNECTION WHILE REAMING. A FRAGMENT WAS GENERATED, BUT IT WAS EASILY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10616675 ↗
• InjuryMay 18, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING FEMUR NAIL USING EXPERT RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN) INSTRUMENTS. THE SURGEON KEPT PUSHING THE DRILL BIT AND IT HEATED UP THE PROTECTION SLEEVE AND BURNED THE SKIN. BOTH INSTRUMENTS WERE FUNCTIONING NORMALLY AND HAVE BEEN USED SINCE THE PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME BONE FIXATION PROCEEDED AS PLANNED, BUT THE PATIENT HAD SKIN BURN WHICH WAS TREATED AND HEALED AS PLANNED. CONCOMITANT DEVICES REPORTED: 13MM PROTECTION SLEEVE-SHORT (PART NUMBER 03.010.229, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 10065429 ↗
• MalfunctionNov 14, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2018, A CANNULATED DRILL BIT BECAME STUCK IN THE GUIDE SLEEVE AND WOULD NOT ROTATE DURING AN UNKNOWN PROCEDURE. BOTH ITEMS WERE REMOVED FROM THE SURGERY. THE NURSE TOOK THEM BACK TO STERILE PROCESSING TO BE CLEANED BY THE TECHNICIAN. AFTER CLEANING, THE DRILL BIT WAS STILL STUCK AND NOT ROTATING. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 13.0MM CANNULATED DRILL BIT 300MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8069542 ↗
• MalfunctionNov 13, 2018Mechanics Altered; Mechanics Altered

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2018, IT WAS NOTED THAT THE 13.0MM CANNULATED DRILL BIT WAS DULL AND WOULD NOT DRILL INTO THE BONE. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT IS FOR ONE (1) 13.0MM CANNULATED DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8065147 ↗
• MalfunctionAug 3, 2018Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTED THAT THE CANNULATED DRILL BIT OPENING REAMER BROKE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7748795 ↗
• MalfunctionOct 5, 2017Break; Break

  IT WAS REPORTED THAT A DRILL BIT BROKE OFF INTO A DRILL CHUCK DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) INTRAMEDULLARY NAIL INSERTION OF THE FEMUR ON (B)(6) 2017. THE DRILL BIT BROKE INTO TWO PIECES AS THE SURGEON WAS DRILLING. THE DRILL USED WAS A STRYKER 7000. THERE WAS NO REPORTED SURGICAL DELAY. FRAGMENTS DID FALL INTO THE PATIENT; BUT,WERE REPORTED AS EASILY REMOVED AND CAUSED NO DELAY OR INTERNAL DAMAGE. THE SURGERY WAS SUCCESSFULLY COMPLETED USING A NEW DRILL BIT. A NAIL AND (4) 5.0MM LOCKING SCREWS WERE IMPLANTED IN THE PATIENT AFTER THE DRILL BIT BROKE. THE PATIENT OUTCOME WAS REPORTED AS GREAT. A REPLACEMENT WAS REQUESTED. CONCOMITANT DEVICES REPORTED: A STRYKER 7000 DRILL (PART NUMBER: UNKNOWN, LOT NUMBER: UNKNOWN, QUANTITY: 1). THIS REPORT INVOLVES 1 DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6915569 ↗
• MalfunctionAug 18, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DIFFICULTY WAS EXPERIENCED WHILE USING A 13MM DRILL BIT DURING AN EMERGENCY RETROGRADE NAILING OF THE FEMUR ON (B)(6) 2017. AS THE SURGEON WENT TO OPEN UP THE CANAL WITH A 13MM REAMER (DRILL BIT), HE WAS STRUGGLING (PUSHING REALLY HARD TO GET THROUGH CORTICAL BONE). IT SEEMED AS IF THE DRILL BIT WAS DULL. THE AGE OF THE DEVICE IS UNKNOWN. THIS IS NOTED TO HAVE BEEN A YOUNG PATIENT WITH VERY HARD BONE. THE SURGEON CONTINUED TO USE IT, BACKED IT OUT AND SWITCHED TO GUIDE WIRES. THE GUIDE WIRE APPEARED SLIGHTLY BENT. FINALLY, THE SURGEON WAS ABLE TO DRILL INTO THE MEDULLARY CANAL. THERE WAS A REPORTED SURGICAL DELAY OF TWO (2) MINUTES DUE TO THE STRUGGLE WITH THE BIT (LONG TIME TO GET TO THE ENTRY POINT OF THE MEDULLARY CANAL). THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICE REPORTED: SYNTHES SMALL TRAUMA DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 13.0MM CANNULATED DRILL BIT. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6805182 ↗