NA 310.67Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982186898), received between Nov 2, 2020 and Sep 30, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device-Device Incompatibility

  It was reported that in the surgical act, when the 1.25 mm guide needle broke while the doctor was using it. A fragment of this needle was stuck together with bone tissue inside the 2.7 mm drill bit, blocking its canal. The surgeon, the scrub nurse and I tried to remove it on the operating table but it was not possible to uncover it, so the drill bit was left clean externally and marked with red tape. This generated a small delay while the fragment was removed, without any discomfort on the part of the doctor, who even collaborated in the process. The eventuality was resolved by requesting another replacement 1.25 mm needle from the institution, successfully placing the last 3.5 mm screw and completing the surgery satisfactorily. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945406 ↗
• MalfunctionMay 29, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THE DRILL BIT COULD NOT BE CLEANED COMPLETELY DUE TO A PIECE OF THE PATIENT¿S BONE BEING STUCK IN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105072 ↗
• MalfunctionOct 3, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN NORWAY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE DRILL BIT BROKE DURING SURGERY. THE SURGERY TIME WAS EXTENDED BY AN UNKNOWN LENGTH OF TIME DUE TO THE EVENT. THIS REPORT INVOLVES ONE 2.7MM CANNULATED DRILL BIT/QC 160MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17859766 ↗
• MalfunctionJul 28, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE DRILLING FOR WITH A 2.7 CANNULATED DRILL BIT, THE WIRE BECAME INCARCERATED INSIDE OF THE DRILL BIT AND WAS PULLED OUT. IT APPEARED THAT THE SURGEON WAS DRILLING AT AN ANGLE AND IT CAUSED THE WIRE TO BIND UP INSIDE OF DRILL BIT. ANOTHER DRILL BIT AND WIRE WERE SELECTED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS 5 MINUTES SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THIS REPORT IS FOR ONE 2.7MM CANNULATED DRILL BIT/QC 160MM FOR (B)(4). THIS COMPLAINT INVOLVES TWO(2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414379 ↗
• MalfunctionJul 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE THE SURGEON WAS DRILLING FOR A SCREW, THE WIRE WAS PULLED OUT BY THE DRILL BIT. THE WIRE WAS UNTHREADED AND THE DRILL BIT ¿SWALLOWED¿ THE WHOLE WIRE, WHICH LIKELY LED TO IT BEING PULLED OUT. THERE WERE NO ADVERSE EVENTS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE 2.7MM CANNULATED DRILL BIT/QC 160MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305274 ↗
• MalfunctionMar 1, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE THE SURGEON WAS DRILLING OVER A WIRE, IT WAS REPORTED THAT THE WIRE WAS STUCK INSIDE DRILL BIT LOSING HIS PLACE. A NEW WIRE WAS PLACED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. NO PATIENT CONSEQUENCE WAS REPORTED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.7MM CANNULATED DRILL BIT/QC 160MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16462811 ↗
• MalfunctionJun 28, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, GUIDE WIRES BREAK AT A HIGH RATE WHEN USED WITH THE DRILL BIT IN QUESTION. THE DRILL BIT WAS PURCHASED BY AN AGENT. THE DATE OF PURCHASE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM CANNULATED DRILL BIT QC 160MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14846550 ↗
• MalfunctionMar 1, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6), 2021, DURING AN UNKNOWN SURGERY, THE 2.7MM CANNULATED DRILL BIT BROKE AT THE PROXIMAL END, JUST BELOW THE SHANK AT THE NECK. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THE PATIENT BONE TENDS TO BE HARD EVEN IN CANCELLOUS BONE. SURGICAL DELAY IS UNKNOWN. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE 2.7MM CANNULATED DRILL BIT/QC 160MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13635649 ↗
• MalfunctionMay 18, 2021Defective Device; Defective Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING THE PROCEDURE, THREE (3) GUIDE WIRES BROKE. FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED BY INSERTING THE CANNULATED SCREWS WITHOUT THE GUIDE WIRES AND WITH THE HELP OF THE IMAGE INTENSIFIER TO VERIFY THAT THE SCREWS WERE CORRECTLY POSITIONED. THE DOCTOR REQUESTED AN INSPECTION OF THE DRILL BIT 2.7 OF CANNULATED SCREWS 3.5 DUE IT PRESENTED AN INTERNAL SHARD THAT MADE THE GUIDE WIRES BREAK. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED DEVICE IT WAS IDENTIFIED THAT THE DISTAL END OF THE DRILL BIT HAD BROKEN OFF. THIS REPORT IS FOR ONE (1) 2.7MM CANNULATED DRILL BIT QC 160MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11841466 ↗
• MalfunctionNov 2, 2020Failure to Cut; Failure to Cut

  ADDITIONAL EVENT INFORMATION : THE REPORTED ISSUE DID NOT CAUSED ANY IMPACT TO THE PATIENT. THERE WAS NO ADDITIONAL INTERVENTION SCHEDULE TO REMOVE BROKEN PIECES FROM THE PATIENT. THE MENTIONED NEEDLE THAT WAS BENT IS REFERS TO THE GUIDEWIRE. THE PATIENT OUTCOME WAS GOOD.

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

  MAUDE report 10774686 ↗