NA 310.63Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886982186812), received between May 1, 2017 and Mar 24, 2026 — classified as 7 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (21 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Failure to Cut

  DURING THE PROCEDURE, WHILE DRILLING WITH DRILL BITS REFERENCES (B)(6) (2 UNITS) // (B)(6) (1 UNIT), IT WAS OBSERVED THAT THE INSTRUMENTS WERE NOT SHARP ENOUGH TO PERFORM THEIR FUNCTION, WHICH HINDERED DRILLING FOR THE SCREWS. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT AFFECTING THE PATIENT OR ALTERING THE SURGICAL SCHEDULE. ALSO, DURING THE PROCEDURE, UPON OPENING THE EQUIPMENT, IT WAS FOUND THAT ONE (1) UNIT OF SCREW REF (B)(6) WAS MISSING FROM THE ANKLE SCREWS. THE REMITTANCE LISTED TWO (2) UNITS, BUT ONLY ONE (1) UNIT WAS PHYSICALLY PRESENT. THIS DID NOT AFFECT THE NORMAL COURSE OF THE SURGERY, AS THIS PARTICULAR SCREW WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672886 ↗
• MalfunctionDec 30, 2025Break; Entrapment of Device; Break; Entrapment of Device

  VOLUNTARY REPORT RECEIVED (B)(4). IT WAS REPORTED DURING A FEMORAL EPIPHYSES PINNING, A <1 MM PORTION OF TWO DRILL BIT REAMER TINES BROKE MIDWAY INTO THE FEMORAL NECK AND WERE RETAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23926699 ↗
• MalfunctionDec 30, 2025Break; Entrapment of Device; Break; Entrapment of Device

  VOLUNTARY REPORT RECEIVED (B)(4). IT WAS REPORTED DURING A FEMORAL EPIPHYSES PINNING, A <1 MM PORTION OF TWO DRILL BIT REAMER TINES BROKE MIDWAY INTO THE FEMORAL NECK AND WERE RETAINED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23926626 ↗
• MalfunctionNov 25, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024 THE DRILL BIT WAS BEING USED ON A CASE IN A PATIENT'S CALCANEUS. AS THE DRILL BIT WAS RUNNING ON FULL POWER, THE BIT BROKE AT THE FLUTES AND WAS SHEARED OFF INTO THE PATIENT. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20772944 ↗
• MalfunctionJul 25, 2024Break; Entrapment of Device; Break; Entrapment of Device

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. THIS REPORT INVOLVES ONE 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19826495 ↗
• MalfunctionMay 6, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT WHILE DRILLING THE TEAM HEARD A SNAP, STOPPED DRILLING BROUGHT IN RADIOLOGY TOOK AN X-RAY AND IT WAS REVEALED THE DRILL BIT SNAPPED IN THREE (3) PIECES. TWO (2) PIECES WERE REMOVED, THE LAST PIECE WAS RETAINED. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19251477 ↗
• MalfunctionMay 6, 2024Break; Entrapment of Device; Device-Device Incompatibility; Noise, Audible; Break; Entrapment of Device; Device-Device Incompatibility; Noise, Audible

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A PROCEDURE, THE DRILL BIT WAS STUCK WITH SHAFT. IT WAS NOTED THE SURGEON HEARD A NOISE WHILE DRILLING. THE DRILLING WAS STOPPED AND OBTAINED IMAGING AND NOTED THAT THE DRILL BIT HAD BROKEN IN SEVERAL PIECES; TWO PIECES WERE REMOVED, AND ONE RETAINED AS SAFEST OPTION FOR PATIENT. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 19249941 ↗
• MalfunctionMar 18, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED ON FEBRUARY 28, 2024 THAT A DRILL BIT WAS BROKEN DURING SURGERY. THIS REPORT IS FOR ONE (1) 5.0 CANNULATED DRILL BIT LARGE QC/300. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18921534 ↗
• MalfunctionOct 16, 2023Break; Break

  DEVICE REPORT FROM NEW ZEALAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023 DURING A PROCEDURE FOR A PELVIC SCREW, THE SURGEON HAD A REAMER BREAK. ALL FRAGMENTS GENERATED WERE RETRIEVED WITH NO ADDITIONAL MEDICAL INTERVENTION. THE DRILL BIT FAILED WHILE OVER A GUIDEWIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. THERE WAS A SURGICAL DELAY OF A FEW MINUTES. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17940423 ↗
• MalfunctionSep 11, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM NEW ZEALAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 24-AUGUST-2023 DURING A SUBTALAR FUSION CASE, A LOAN 7.3MM CANNULATED SCREW SET WAS BEING USED. THE 5.0MM CANNULATED DRILL BIT IN THE SET WAS FOUND TO BE BLUNT WHEN THE SURGEON WAS USING IT. THE SURGEON WAS ABLE TO COMPLETE THE DRILLING, BUT SWITCHED TO THE OTHER BIT IN THE SET FOR THE REMAINING SCREWS. NO FRAGMENTS WERE GENERATED, THERE WAS NO ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719326 ↗
• MalfunctionJun 26, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BIT WAS DULL. THE PROCEDURE WAS ABLE TO BE FINISHED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17197856 ↗
• InjuryJan 25, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INTRA-OP WHILE THE SURGEON WAS USING THE 5.0MM DRILL INTRAOP, THE TIP BROKE INSIDE THE PATIENT. TWO PIECES BROKE OFF INSIDE THE HIP. THE SURGEON RETRIEVED ONE PIECE AND ATTEMPTED TO RETRIEVE THE SECOND PIECE BUT WAS UNSUCCESSFUL. THIS REPORT IS FOR ONE (1) 5.0 CANNULATED DRILL BIT LARGE QC/300. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16241899 ↗
• InjuryJan 11, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, THE TIP OF THE DRILL BIT BROKE OFF IN THE BONE WHEN DRILLING. PART OF THE PIECE WAS RECOVERED, PART OF THE PIECE WAS LEFT IN THE BONE. RETRIEVED WHAT THEY COULD AND USED A NEW DRILL BIT TO FINISH CASE. PART OF THE DRILL BIT WAS RETRIEVED, PART OF IT WAS LEFT IN AFTER UNSUCCESSFULLY TRYING TO RETRIEVE IT. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE PROCEDURE COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0 CANNULATED DRILL BIT LARGE QC/300. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16141272 ↗
• MalfunctionDec 21, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, A 5.0MM CANNULATED DRILL BIT LARGE QC/300MM BROKE DURING A RIGHT FEMORAL VARUS DEROTATION OSTEOTOMY. THE PATIENT WAS NOT AFFECTED BY THE EVENT. THE CASE WAS DELAYED BY 1.5-2 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022047 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE TIP OF THE DRILL BIT IN QUESTION BROKE OFF INTO THE PELVIS OF THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789224 ↗
• MalfunctionNov 11, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, ONE 5.0MM DRILL BIT FROM THE 7.3MM CANNULATED SCREW SET BROKE OFF INSIDE A PATIENT. IT DID NOT APPEAR THAT ANY FRAGMENTS WERE LEFT INSIDE THE PATIENT¿S BODY. THERE WAS SURGICAL DELAY OF 10 MINUTES, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15780987 ↗
• MalfunctionJul 29, 2022Break; Break

  IT WAS REPORTED ON JULY 4, 2022, THAT WHILE DRILLING THE 5.0MM CANNULATED DRILL BIT OVER THE 2.8 MM GUIDE WIRE IN THE PELVIS, THE DRILL BIT BROKE OFF IN SEVERAL PIECES. GUIDE WIRE WAS REMOVED ALONG WITH THE REMAINING DRILL BIT THAT COULD BE RETRIEVED. THE PROCEDURE COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 5 MINUTES. THERE WERE FRAGMENTS GENERATED BUT THEY WERE NOT REMOVED. THE PATIENT CONSEQUENCES WERE UNKNOWN. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR ONE (1) 5.0 CANNULATED DRILL BIT LARGE QC/300. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135785 ↗
• MalfunctionApr 19, 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) 2021, THE DRILL BIT WAS NOT SHARP. THERE WAS NO PATIENT CONSEQUENCES. NO MORE INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT INVOLVES ONE (1) 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14140821 ↗
• MalfunctionSep 16, 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) 2021, THE DRILL BIT WAS DULL. THERE WAS NO SURGICAL DEALY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12482148 ↗
• InjuryMay 25, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE SURGERY A SUBTALAR ARTHRODESIS PROCEDURE USING HEADLESS COMPRESSION SCREWS SURGEON USED TWO GUIDE WIRE TO GUIDE THE SCREW PLACEMENT. WHILE PRE-DRILLING FOR THE SECOND SCREW THE DRILL BIT MADE CONTACT WITH THE FIRST SCREW THE CANNULATED DRILL BIT LARGE BROKE OFF. THE PIECE OF THE DRILL BIT THAT BROKE OFF REMAINED IN THE PATIENT, AS IT WOULD LIKELY CAUSE MORE TRAUMA TO THE PATIENT'S BONE TO ATTEMPT TO REMOVE IT. SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT FURTHER COMPLICATION AND WITH A SURGICAL DELAY. CONCOMITANT DEVICES REPORTED: HEADLESS COMPRESSION PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), GUIDE WIRE (PART# 292.68, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR (1) 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11878160 ↗
• InjuryJan 8, 2021Entrapment of Device; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN ELBOW FRACTURE PROCEDURE ON (B)(6) 2020, THE TIP OF THE 5.0 DRILL BIT WAS BROKEN. THE ISSUE OCCURRED WHILE DRILLING THE CORTEX WITH THE 6.5 AND 7.3MM CANNULATED SCREW AT THE WASHER. THE BROKEN PIECE OF THE DRILL BIT WAS NOT ABLE TO BE RETRIEVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY PROCEEDING WITH SCREW PLACEMENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN 6.5MM/7.3MM CANNULATED SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN WASHER (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN), UNKNOWN 2.8MM K WIRE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11139488 ↗
• MalfunctionJan 10, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE DRILL BIT BROKE INSIDE OF THE PATIENT. THE SURGEON WAS USING THE 5.0 CANNULATED DRILL BIT OUT OF THE 6.5MM/7.3MM CANNULATED SCREW AND INSTRUMENT SET. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. IT UNKNOWN IF THERE WAS A SURGICAL DELAY. IT IS UNKNOWN IF PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9576080 ↗
• InjuryDec 19, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING SURGERY OF THE RIGHT HIP SLIPPED CAPITAL FEMORAL EPIPHYSIS (SCFE) FRACTURE THREADED PERCUTANEOUSLY WITH THE CANNULATED SCREW. DURING THE PROCEDURE, THE GUIDE WIRE WAS PLACED IN THE FEMORAL HEAD. THE DRILL WAS USED OVER THE GUIDE WIRE AND DURING INSERTION, THE TIP OF THE DRILL BIT BROKE OFF. SOME OF THE FRAGMENTS WERE RETRIEVED IN ABOUT 5-10 MINUTES AND SOME WERE STILL LEFT IN THE HIP. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT'S STATUS WAS FINE. CONCOMITANT DEVICE REPORTED: UNKNOWN CANNULATED SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1), UNKNOWN GUIDE WIRE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 5.0MM CANNULATED DRILL BIT LARGE QC/300MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9494814 ↗
• InjuryNov 19, 2019Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS DRILLING THROUGH THE LATERAL CORTEX OVER THE 2.8 GUIDE WIRE FOR A 6.5 CANNULATED SCREW IN A HIP PINNING CASE. THE DRILL BIT BROKE OFF AS HE WAS GOING TOWARDS THE MEDIAL CONDYLE THEN HE STOPPED THE DRILL AND PULLED OUT. A FRAGMENT OF THE DRILL BIT GOT EMBEDDED IN THE PATIENT'S BONE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY AND PATIENT OUTCOME WAS GOOD. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9342390 ↗
• MalfunctionNov 12, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED ON AN UNKNOWN DATE THAT DURING A SLIPPED CAPITAL FEMORAL EPIPHYSIS (SCFE) SURGERY WITH 6.5 CANNULATED SCREWS ON (B)(6) 2019, A TINY PIECE OF THE TIP OF A CANNULATED DRILL BIT BROKE OFF INTO THE PATIENT. AS THE DRILL BIT WAS BEING ADVANCED OVER THE GUIDE WIRE AND INTO THE BONE, IT HIT THE WIRE AND A SMALL PIECE OF THE DRILL BIT BROKE OFF. THE BROKEN FRAGMENT WAS RETAINED IN THE PATIENT'S BODY AND NO RETRIEVAL ATTEMPT WAS MADE AS IT WAS NOT IN THE WAY. THERE WAS NO REPORTED SURGICAL DELAY. UNABLE TO REMOVE FRAGMENTS. THE SURGERY WAS COMPLETED BY PLACING THE SCREW OVER THE WIRE IN THE CORRECT PLACE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN GUIDE WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 9312323 ↗