NA 310.509Recalls & reported problems

Summary

The FDA's MAUDE database contains 145 adverse event reports that list this exact device (DI 10886982186744), received between Apr 3, 2017 and Sep 29, 2026 — classified as 12 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Break” (123 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 145 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Break; Entrapment of Device

  It was reported that during the procedure the 1.8 drill bit broke, with the tip remaining inside the distal radius bone. Since it did not protrude and did not pose a risk to the patient, they decided to leave it in place and continue the procedure normally. There was no patient harm or surgical delay.

  Patient problems: Foreign Body In Patient

  MAUDE report 50933285 ↗
• MalfunctionAug 11, 2026Break; Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211378 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE AND LCP DRILL SLEEVE 2.4 W/SCAL-30 F/DRILL B WERE INVOLVED IN AN EVENT. DURING AN ORIF PROCEDURE FOR A DISTAL RADIUS FRACTURE, THE DRILL TIP BROKE OFF, LEAVING APPROXIMATELY 3 MM EMBEDDED IN THE CORTEX. THE TIP WAS EXTRACTED BY MAKING A DORSAL INCISION AND DISASSEMBLING THE AREA. THE DRILL GUIDE WAS DIFFICULT TO REMOVE, SUGGESTING IMPROPER FITTING DURING DRILLING, WHICH MAY HAVE CONTRIBUTED TO THE BREAKAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30-MINUTE DELAY. THERE WAS NO IMPACT TO THE EXPECTED SURGICAL OUTCOME, AND NO PATIENT CONSEQUENCES OR CLINICAL SYMPTOMS WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001949 ↗
• MalfunctionApr 13, 2026Failure to Cut

  THE DULL DRILL BIT DAMAGES THE BONE WHEN DRILLING. THE GAUGE IS BENT, SO IT DOESN'T SLIDE EASILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858509 ↗
• MalfunctionMar 31, 2026Break

  IT WAS REPORTED THAT DURING THE SURGERY, THE DRILL BIT IN QUESTION BROKE. NO REMNANTS WERE FOUND IN THE PATIENT'S BODY. THE SURGEON COMMENTED THAT IT WAS A PROCEDURAL ISSUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744668 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THE PATIENT UNDERWENT AN ORIF PROCEDURE FOR DISTAL RADIUS FRACTURE. DURING THE SURGERY, THE DRILL BIT BROKE DURING NORMAL USE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT. IMAGING CONFIRMED IT WAS NOT PRESENT INSIDE THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505588 ↗
• MalfunctionFeb 10, 2026Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL RADIUS FRACTURES. DURING THE SURGERY, THE PRODUCT IN QUESTION WAS CONNECTED TO A HAND PIECE AND USED, BUT IT CAUSED SIGNIFICANT CORE RUNOUT. THE SURGERY WAS COMPLETED SUCCESSFULLY USING ANOTHER DRILL BIT WITH NO SURGICAL DELAY. THE HOSPITAL SUSPECTED THAT THE DRILL BIT MAY HAVE BEEN SHIPPED IN A DEFORMED STATE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306328 ↗
• MalfunctionJan 12, 2026Break

  A DRILL BIT WAS FOUND BROKEN IN A SET. THERE WAS NO PATIENT INVOLVEMENT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037719 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. DURING THE SURGERY, THE SURGEON PERFORMED DRILLING AT AN ANGLE, AND THE PRODUCT IN QUESTION BROKE OFF. AFTER RETRIEVING THE BROKEN TIP OUTSIDE THE PATIENT¿S BODY, THE OTHER DRILL BIT WAS USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AN IMAGE INTENSIFIER WAS USED BEFORE CLOSING THE WOUND AND SHOWED NO METAL FRAGMENTS INSIDE THE PATIENT¿S BODY. X-RAYS TAKEN AFTER THE SURGERY ALSO SHOWED NO PROBLEMS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957648 ↗
• MalfunctionNov 21, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN ORIF OF THE FOURTH METACARPAL OF THE RIGHT HAND, A PIECE OF THE DRILL BIT BROKE OFF IN THE BONE. THE SURGEON WAS UNABLE TO RETRIEVE THE FRAGMENT AS DOING SO WOULD CAUSE MORE DAMAGE THAN LEAVING IT IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23617450 ↗
• MalfunctionAug 25, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BROKE DURING DRILLING; ALL FRAGMENTS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884444 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR RADIUS WITH DRILL BIT. WHILE THE SURGEON WAS DRILLING, THE DRILL BIT BROKE. THE BROKEN END WAS STUCK IN THE PROXIMAL SLEEVE, SO THERE WERE NO FRAGMENTS IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701449 ↗
• MalfunctionJul 30, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL RADIUS FRACTURE WITH THE DRILL BIT. THE DRILL BIT BROKE DURING THE SURGERY. AFTER DRILLING, THE NURSE NOTICED THE DRILL WAS BROKEN OUTSIDE THE SURGERY FIELD. SO, THE SURGEON REPLACED IT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666372 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE DRILLING, THE 1.8MM DRILL BIT BROKE IN THE DISTAL RADIUS. THE DRILL BIT TOGETHER WITH ITS FRAGMENTS WAS REMOVED AND ANOTHER DRILL BIT OF THE SAME CHARACTERISTICS THAT ALSO COMES INSIDE THE EQUIPMENT WAS PASSED ON TO SURGEON FOR USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT IMPACT AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644164 ↗
• MalfunctionJul 3, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT ORIF SURGERY FOR DISTAL RADIUS FRACTURE WITH THE DRILL BIT. DURING SURGERY, THE DRILL BIT BROKE OFF. THE BROKEN DRILL BIT WAS RETRIEVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393969 ↗
• MalfunctionMar 20, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR DISTAL RADIUS FRACTURE WITH THE DRILL BIT IN QUESTION. IN THE SURGERY, VA-TCP SMALL 5 HOLES WERE USED. DURING DRILLING OF THE PROXIMAL LHS2.4 SCREW, THE F1.8 DRILL TIP BROKE. THE DETAILED CAUSE IS UNKNOWN. IT SEEMED THAT WHEN REMOVING THE DRILL FROM THE SLEEVE, IT GOT CAUGHT AND BROKE. THE BROKEN TIP WAS RECOVERED, AND IT WAS CONFIRMED THAT NO METAL PIECES REMAINED INSIDE THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655295 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT THE DRILL BIT IS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798768 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DRILL BIT IN QUESTION. IN THE SURGERY, THE PRODUCT BROKE WHEN DRILLING. THE SURGEON OPINED THAT THE BREAKAGE WAS CAUSED BY DRILLING UNDER TENSION. SINCE THE BREAKAGE HAPPENED WHEN THE PRODUCT WAS IN THE SLEEVE, THERE WERE NO RESIDUALS IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666164 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 THE DRILL BIT WAS BROKEN.

  Patient problems: Insufficient Information

  MAUDE report 20516320 ↗
• MalfunctionOct 23, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS A BROKEN DRILL BIT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514547 ↗
• MalfunctionSep 26, 2024Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2024, THE 1.8 DRILL BIT PARTED. THERE WAS NO PATIENT HARM OR DELAY IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20312497 ↗
• MalfunctionSep 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 , DURING A SURGERY WITH A PLATE FOR A RADIAL DIAPHYSEAL FRACTURE, THE DRILL BIT GOT DAMAGED WHILE DRILLING. THE SURGEON CONFIRMED BY X-RAY THAT NO PIECES WERE LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2024 IT WAS IDENTIFIED THAT THE FLUTED TIP OF THE DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE WAS BROKEN. THIS REPORT IS FOR ONE (1) 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20136697 ↗
• MalfunctionSep 3, 2024Break; Entrapment of Device; Improper or Incorrect Procedure or Method; Break; Entrapment of Device; Improper or Incorrect Procedure or Method

  IT WAS REPORTED A DRILL BIT BROKE DURING A PROCEDURE. A SECOND DRILL BIT WAS AVAILABLE SO THERE WAS NO IMPACT TO THE PROCEDURE, AND IT WAS COMPLETED WITH NO DELAY. IT WAS NOTED A BROKEN PIECE OF THE DRILL BIT WAS LEFT IN THE PATIENT. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20127900 ↗
• MalfunctionApr 23, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON MARCH 20, 2024, THE CUSTOMER COMPLAINED ABOUT A DEFECTIVE SCREWDRIVER TIP, THE THREAD DID NOT FIT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 1.8MM DRILL BIT WITH DEPTH MARK/QC/110MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163409 ↗
• MalfunctionMar 14, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF WITH RHP IMPLANT FOR BOTH SIDE OF FIBULAR HEAD. AFTER ALL SCREWS WERE INSERTED AND THEN WHILE WOUND CLOSURE WAS UNDER WAY, ASSISTANT SURGEON DISCOVERED APPROXIMATE 10 MM FRACTION ON AN OPERATING TABLE. WHEN COMPARING A FIRST DRILL WITH A BACKUP ONE, THE FIRST DRILL¿S BIT PORTION WAS CONFIRMED TO BE BROKEN OFF. A TOP SURGEON CHECKED INSIDE OF PATIENT¿S BODY THROUGH X-RAY, AND IT WAS MADE SURE THERE WERE NOT ANY FRACTIONS IN THE PATIENT¿S BODY. AFTER THAT, THE BACKUP DRILL WAS USED TO RESTART FIXING A SCREW FROM SECOND LATERAL LOCATION, AND THE SURGERY WENT ON. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE DRILL BIT Ø1.8 W/MARKING L110/85 2FLUTE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903374 ↗