NA 310.31Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982186478), received between Jan 11, 2018 and Feb 20, 2026 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT TWO DRILL BITS WERE RECEIVED BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402834 ↗
• MalfunctionFeb 20, 2026Break

  IT WAS REPORTED THAT TWO DRILL BITS WERE RECEIVED BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402824 ↗
• MalfunctionJan 6, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE DEVICE WAS RECEIVED AS BLIND UNIT. DURING THE VISUAL EXAMINATION PERFORMED ON (B)(6) 2025 THE DEVICE WAS FOUND WORN AND DULL FROM THE EDGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981462 ↗
• MalfunctionMar 24, 2025Device-Device Incompatibility; Device-Device Incompatibility

  WENT TO GO DRILL IN 4.5 CORTICAL COMPRESSION SCREW. ASSEMBLED 3.2 DRILL BIT AND SLIPPED ON 3.2 DRILL SLEEVE ONTO POWER DRILL. DR. (SURGEON) WENT TO DRILL FOR SCREW WHERE IT LOCKED AND STARTED SPINNING THE WHOLE DRILL IN HER HANDS SHE GAVE IT A LIGHT POWER TOUCH, IT CONFIRMED THE DRILL BIT WAS STUCK IN THE SLEEVE. IT WAS UNABLE TO BE REMOVED. ANOTHER 3.2 DRILL BIT WITHOUT THE SLEEVE WAS USED TO CONTINUE THE CASE. THE SURGERY WAS DELAYED 2 MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678630 ↗
• MalfunctionJan 22, 2025Break; Break

  IT WAS REPORTED DURING A SURGICAL PROCEDURE ON (B)(6) 2025, A DRILL BIT BROKE.

  Patient problems: Insufficient Information

  MAUDE report 21210376 ↗
• MalfunctionJul 11, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, A 3.2 MM DRILL BIT BROKE WHEN DRILLING FOR AN OPEN REDUCTION/INTERNAL FIXATION SURGERY TO REPAIR A PERIPROSTHETIC FEMUR FRACTURE. THE SURGEON WAS DRILLING DIRECTLY AGAINST TO HIP IMPLANT. FRAGMENTS WERE GENERATED, AND THE SURGEON DID NOT ATTEMPT REMOVAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE 3.2MM DRILL BIT/QC/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

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

  MAUDE report 19722266 ↗
• MalfunctionMay 22, 2024Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, THE 3.2 BITS OF HAVE NO CUT AND WERE FOLDED AT THE MOMENT OF USE. THIS REPORT IS FOR A 3.2MM DRILL BIT/QC/145MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19370523 ↗
• MalfunctionDec 13, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, A PROCEDURE FOR A PERTROCHANTERIC LEFT HIP FRACTURE WAS TREATED BY THE IMPLANTATION OF THE DHR (DYNAMIC HIP SCREW). DURING THE PROCEDURE, THE SURGEON USED A DRILL BIT WHEN INSERTING THE CERVICAL SCREW, WHICH HE PASSED INTO THE FEMORAL HEAD AND ALSO PLACED IN THE ACETABULUM. HE DID THIS TO AVOID ROTATION OF THE FEMORAL HEAD WHEN SCREWING THE IMPLANT 'ANTI-ROTATION EFFECT'. THE SURGEON USED THE ANCILLARY TO PREPARE THE LODGE OF THE CERVICAL SCREW THEN SCREWS THE IMPLANT INTO THIS SAME LODGE. THE DRILL BIT BROKE DURING IMPLANTATION OF THE CERVICAL SCREW. A PIECE OF THE DRILL WAS PRESENT IN THE FEMORAL HEAD AND IN THE ACETABULUM, BUT DO NOT NO LONGER FULFILLS ITS 'ANTI-ROTATION' FUNCTION. IN ORDER TO OBTAIN THE ANTI-ROTATION EFFECT AGAIN, THE SURGEON USED A METALLIC PIN. WHEN HE PASSED THE PIN, IT PASSED IN THE SAME PATH LEFT BY THE BROKEN DRILL, AND PUSHED THE DRILL PIECES IN THE SMALL PELVIS. THE IMPLANTS WERE PLACED AND THE OPERATIVE WOUND WAS CLOSED. THE PATIENT LEFT THE OPERATING ROOM WITH THE FOREIGN BODY REMAINING IN THE SMALL PELVIS. CONSIDERED ACTION : INSERT A URINARY CATHET

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18318407 ↗
• MalfunctionSep 28, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 12-SEPTEMBER-2023, THE DRILL BITS IN QUESTION WERE FOUND TO BE DULL AND WOULD NOT CUT AS INTENDED. THE DRILL BITS DID NOT PASS THROUGH THE BONE, CAUSING OVERHEATING AND A DELAY IN REDUCTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.2MM DRILL BIT/QC/145MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839611 ↗
• InjuryMar 31, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FEMUR PROCEDURE, THE 3.2MM DRILL BIT WAS USED TO PRE-DRILL A HOLE FOR A 4.5MM CORTICAL SCREW. THE END OF THE DRILL BIT BROKE INSIDE THE PATIENT'S BONE. THE SURGEON DETERMINED RETRIEVAL OF THE DRILL BIT WAS NOT POSSIBLE AND IT WAS RETAINED INSIDE THE PATIENT'S BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW DRILL BIT. THERE WAS NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: CORTEX: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 3.2MM DRILL BIT/QC/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11599568 ↗
• InjuryNov 13, 2020Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL EVENT DESCRIPTION. CONCOMITANT DEVICE REPORTED: UNKNOWN BONE CEMENT (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1).

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 10837264 ↗
• MalfunctionOct 1, 2020Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE DRILL BITS WERE BLUNT. PATIENT INVOLVEMENT WAS UNKNOWN. THIS REPORT INVOLVES ONE (1) 3.2MM DRILL BIT/QC/145MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10612500 ↗
• InjuryJun 22, 2020Break; Entrapment of Device; Break; Entrapment of Device

  UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT ON (B)(6) 2020, DURING A PROXIMAL TIBIAL CASE, THE TWO (2) 4.3 DRILL BIT AND ONE (1) 3.2 DRILL BIT WERE BROKEN OFF IN THE PATIENT. THERE WERE FRAGMENTS GENERATED BUT THE BROKEN DRILL BITS REMAINED INSIDE OF THE PATIENT TIBIA BECAUSE THE SURGEON WAS NOT ABLE TO RETRIEVE THEM. THE SALES CONSULTANT WAS PRESENT DURING THE SURGERY. THE SURGEON WAS DRILLING INTO CEMENT AND TRYING TO MANEUVER AROUND A TOTAL KNEE IMPLANT, AND WANTED TO SEE IF IT WAS POSSIBLE TO GET A LETTER OR JUST CONFIRMATION THAT THE DRILL BITS ARE CT SAFE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS STABLE. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 10179020 ↗
• MalfunctionOct 8, 2018Material Deformation; Material Deformation

  VETERINARY COMPLAINT: IT WAS REPORTED THAT ON AN UNKNOWN DATE, NINE (9) SCREWS WERE INCORRECTLY LABELED AND MISSING FROM THE LARGE FRAGMENT INSTRUMENT SET AND THE DRILL BIT HAD A BAD TIP. THIS WAS DISCOVERED WHEN THE SETS WERE RECEIVED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS VETERINARY COMPLAINT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7945139 ↗
• MalfunctionJan 11, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY OF THE RIGHT DISTAL FEMUR ON (B)(6) 2017 TO TREAT A FRACTURE. WHILE THE SURGEON WAS DRILLING WITH A 3.2MM DRILL BIT, THE TIP OF THE DRILL BROKE OFF. THE FRAGMENT WAS RETRIEVED. A BACK-UP DRILL BIT WAS AVAILABLE FOR SURGEON TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED DELAY. NO HARM WAS REPORTED TO THE PATIENT. PATIENT OUTCOME WAS REPORTED STABLE. CONCOMITANT DEVICES REPORTED: DRILL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY:1). THIS REPORT IS FOR ONE (1) 3.2MM DRILL BIT/QC/145MM. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7183657 ↗