NA 310.15Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886982186027), received between Mar 28, 2017 and Sep 23, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Overheating of Device

  It was reported that the drill bit suffers a burn on its tip during the drilling, the surgery is successfully completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867685 ↗
• MalfunctionMar 13, 2026Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE DRILL BIT BREAKS. THIS DOES NOT CAUSE HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590915 ↗
• MalfunctionDec 30, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THE DRILL BITS WERE DULL WHEN DRILLING THE CHANNEL. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921716 ↗
• MalfunctionDec 30, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THE DRILL BITS WERE DULL WHEN DRILLING THE CHANNEL. ANOTHER DRILL BIT WAS USED TO COMPLETE THE PROCEDURE WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921691 ↗
• MalfunctionJan 30, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2022, A 1.5 AO ANCHOR DRILL BIT HAD NO TIP. THERE WAS NO SURGICAL DELAY IN RELATION TO THE EVENT. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE1.5MM DRILL BIT/QC/85MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16264535 ↗
• MalfunctionSep 29, 2022Failure to Cut; Failure to Cut

  THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504268 ↗
• MalfunctionSep 29, 2022Failure to Cut; Failure to Cut

  THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS/ OUTCOME: OK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15504080 ↗
• MalfunctionAug 10, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BIT IN QUESTION WAS FOUND TO BE DULL. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THIS REPORT IS FOR A 1.5MM DRILL BIT/QC/85MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200296 ↗
• MalfunctionJan 5, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE IT WAS NOTED THAT THE 1.5 DRILL BIT WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/QC/85MM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172250 ↗
• MalfunctionSep 1, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/QC/85MM THIS REPORT IS 4 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410615 ↗
• MalfunctionSep 1, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/QC/85MM THIS REPORT IS 7 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410614 ↗
• MalfunctionSep 1, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/QC/85MM. THIS REPORT IS 6 OF 10 FOR (B)(4). RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410573 ↗
• MalfunctionSep 1, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TEN (10) DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/QC/85MM. THIS REPORT IS 5 OF 10 FOR (B)(4) RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410546 ↗
• MalfunctionAug 30, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT ALL OF THE DRILL BITS ARE DULL. IT WAS UNKNOWN IF THERE WAS ANY PROCEDURE INVOLVED. THERE WERE NO PATIENT CONSEQUENCES ARE REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES 30 DEVICES. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/QC/85MM. THIS REPORT IS 2 OF 20 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388747 ↗
• MalfunctionNov 17, 2020Break; Break

  IT WAS REPORTED THAT DURING FOOT PROCEDURE ON (B)(6) 2020, THE 1.5MM DRILL BIT BROKE OFF IN DRILL SLEEVE. CONCOMITANT DEVICE REPORTED: 2.0MM/1.5MM DOUBLE DRILL SLEEVE (PART # 312.220, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10852469 ↗
• MalfunctionSep 23, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, THE DRILL BIT BROKE WHEN IT STOPPED DRILLING. THERE WAS NO PIECE LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) 1.5MM DRILL BIT/QC/85MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10574319 ↗
• MalfunctionAug 3, 2020Break; Break

  THE PROCEDURE PERFORMED WAS OSTEOSYNTHESIS OF THE ULNA-LEFT FINGER. ANOTHER UNKNOWN DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DRILL FRAGMENT GENERATED THAT WAS REMOVED. THERE WAS AN UNKNOWN SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10358157 ↗
• InjuryMar 28, 2017Break; Break

  IT WAS REPORTED THAT DURING A BUNION SURGERY ON (B)(6) 2017, THE 1.5 MM DRILL BIT TIP BROKE INSIDE THE 2.0 MM/1.5 MM DOUBLE DRILL SLEEVE GUIDE. AS THE SURGEON WAS DRILLING IN THE FAR CORTEX OF THE BONE, USING THE LAG SCREW TECHNIQUE, AS HE ATTEMPTED TO DRILL WITH THE DRILL BIT THRU THE DOUBLE DRILL GUIDE THE TIP PORTION OF THE DRILL BIT BROKE OFF INSIDE THE DRILL GUIDE. THE ENTIRE FRAGMENT WAS RETAINED INSIDE THE DRILL GUIDE. ADDITIONAL IMAGES WERE TAKEN TO ENSURE THAT NO OTHER FRAGMENTS WERE GENERATED. DUE TO THIS EVENT NO ADDITIONAL TIME WAS ADDED IN THE OPERATING ROOM. SURGERY WAS COMPLETED SUCCESSFULLY AND PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICE: 2.0 MM/1.5 MM DOUBLE DRILL SLEEVE (ITEM # 312.22, LOT 2038, QUANTITY 1 EACH). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 6438765 ↗