NA 310.25Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 10886982186317), received between Apr 14, 2017 and May 12, 2026 — classified as 31 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Break” (67 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 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Failure to Cut

  IT WAS REPORTED THAT THE DRILL BIT Ø2.5 L110/85 2FLUTE F/QUICK CO PRESENTED DIFFICULTY IN DRILLING CORTICALS DURING A PROCEDURE DUE TO THE DRILL BIT BEING WITHOUT EDGE. THE ISSUE WAS RESOLVED INTRAOPERATIVELY BY USING OTHER AVAILABLE BITS, ALLOWING THE SURGERY TO BE COMPLETED SUCCESSFULLY WITHOUT IMPACT OR CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148482 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED WHEN THE DR. IS BROCKING THE BONE AND PIERCING THE FIRST CORTICAL, THE TIP OF THE BIT IS BROKEN. FRAGMENT IS REMOVED FROM THE BONE AND THE SURGERY CONTINUES WITH ANOTHER DEVICE WITHOUT INCONVENIENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769806 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THE DEVICE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750539 ↗
• MalfunctionSep 10, 2025Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING SURGERY. THE SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017915 ↗
• MalfunctionMar 31, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, AFTER A TIBIAL NAIL WAS INSERTED, THE SURGEON WANTED TO AUGMENT THE FIXATION WITH A 5 HOLE LCP 1/3 TUBULAR PLATE. WHEN DRILLING WITH A 2.5 DRILL BIT IN A HIGH IMPLANT TRAFFIC AREA, THE DRILL BIT BROKE AT THE FLUTED END AND WAS RETAINED IN THE PATIENT COMPLETELY IN THE TIBIA. THE SURGEON WAS NOT CONCERNED AND MOVED ON WITH NO DELAY. THERE WAS PATIENT CONSEQUENCES. A SMALL PIECE OF THE DRILL BIT WAS LEFT INSIDE THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21730556 ↗
• MalfunctionMar 20, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT WHEN THE SURGEON WAS USING A DRILL TO CREATE A HOLE FOR THE SUTURE, THE DRILL BIT BROKE IN THE PATIENT'S BONE. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE STUCK IN THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21655014 ↗
• MalfunctionAug 26, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DOCTOR WAS DOING A TOTAL SHOULDER WITH DJO AND OPENED THE LCP SMALL FRAG FOR A DRILL BIT. THE SYNTHES 2.5MM DRILL BIT BEING USED BROKE OFF IN THE PATIENT'S SCAPULA AND IT WAS NOT RETRIEVED. THERE WAS A FIFTEEN (15) MINUTES OF SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 20065404 ↗
• MalfunctionAug 26, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON JUNE 4, 2024 A 2.5MM DRILL BIT OUT OF THE LCP SMALL FRAGMENT WAS BROKEN OFF IN THE PATIENT AND THE BROKEN FRAGMENT WAS NOT RETRIEVED FROM THE PATIENT. THE PATIENT AND STAFF IS INQUIRING IF THE PATIENT CAN GET AN MRI AND WHAT THE COMPATIBILITY IS. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20065231 ↗
• MalfunctionJun 3, 2024Break; Entrapment of Device; Break; Entrapment of Device

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER MW5154002. THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19447706 ↗
• MalfunctionMar 25, 2024Break; Break

  THERE WAS NO SURGICAL DELAY REPORTED TO THE RELATED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS/OUTCOME REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967422 ↗
• MalfunctionMar 25, 2024Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  THERE WAS NO SURGICAL DELAY REPORTED TO THE RELATED EVENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS/OUTCOME REPORTED AS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967421 ↗
• MalfunctionFeb 26, 2024Failure to Cut; Failure to Cut

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME IS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778003 ↗
• MalfunctionFeb 26, 2024Failure to Cut; Failure to Cut

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME IS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777997 ↗
• MalfunctionFeb 26, 2024Failure to Cut; Failure to Cut

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT OUTCOME IS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18777996 ↗
• MalfunctionFeb 15, 2024Failure to Cut; Material Deformation; Failure to Cut; Material Deformation

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024 THE DRILL BITS IN QUESTION WERE NOT CUTTING. IT BECAME NECESSARY TO EXERT GREATER PRESSURE FOR THE DRILL BIT TO ENTER. ADDITIONALLY, THE DRILL BIT WAS BENT DURING DRILLING. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

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

  MAUDE report 18710740 ↗
• MalfunctionFeb 13, 2024Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 31-JANUARY-2024 DURING AN UNKNOWN PROCEDURE, THE DRILL BIT IN QUESTION BROKE. THE SURGERY WAS FINISHED WITHOUT ANY ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 1 OF 1 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18694871 ↗
• MalfunctionDec 15, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 21-NOVEMBER-2023, THE DRILL BIT IN QUESTION DEFLECTED THE DISTAL END ON CONTACT WITH A SCREW. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334390 ↗
• MalfunctionOct 19, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, THE DRILL BIT IN QUESTION BROKE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17965842 ↗
• InjuryAug 3, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2023, THE TR ITEM WAS BEING USED IN SURGERY AND THE DRILL BIT BROKE OFF. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17451595 ↗
• MalfunctionAug 1, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING AN UNKNOWN PROCEDURE THE DRILL BITS IN QUESTION WERE FOUND TO BE BLUNT. THEIR PASSAGE THROUGH THE BONE WAS DELAYED, THE DRILL BITS DID NOT CUT AS EXPECTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434586 ↗
• MalfunctionJun 2, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT THE DEVICE WAS RECEIVED AS A BLIND UNIT FROM COLOMBIA ON (B)(6) 2023. IT WAS NOTED UPON PRODUCT EXAMINATION THAT THE FLUTED TIP OF THE DEVICE WAS ROUNDED AND BLUNT. THIS REPORT INVOLVES ONE 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051880 ↗
• MalfunctionMay 3, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6), WHILE DRILLING, THE 2.5 DRILL BIT HAD DIFFICULTY DRILLING THROUGH THE BONE. THE SURGERY WAS SUCCESSFULLY COMPLETED, WITH NO SURGICAL DELAY. THERE WAS NO PATIENT OUTCOMES REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861934 ↗
• MalfunctionMar 27, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE 2.5MM GOLD DRILL BIT BROKE, CAUSING THE TIP OF THE DRILL TO BECOME LODGED IN THE PATIENT¿S BONE. THE DRILL BIT WAS COMPLETELY STUCK IN THE BONE, AND IT TOOK THE SURGEON APPROXIMATELY 30-45 MINUTES TO FREE THE BROKEN TIP OF THE DRILL. THE EVENT CAUSED SIGNIFICANT X-RAY EXPOSURE AND ADDED TIME TO THE CASE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 1 OF 1 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620436 ↗
• MalfunctionMar 21, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON THE UNKNOWN DATE, THE CUSTOMER SAID THEIR 2.5 MM DRILL BITS HAD GONE DULL.. NO PATIENT INVOLVEMENT WAS THERE. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16581560 ↗
• InjuryMar 20, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 WHILE DRILLING THE 2.5MM DRILL BIT BROKE A SCREW HOLE IN THE BONE THROUGH A PLATE AND RETAINED IN THE BONE. THE SURGEON MADE THE DECISION THAT ATTEMPTING TO RETRIEVE THE RETAINED BROKEN SECTION OF DRILL BIT WOULD CREATE MORE DAMAGE AND SO DECIDED TO LEAVE IT IN THE BONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 2.5MM DRILL BIT/QC/GOLD/110MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16575133 ↗