EVOS 71174930Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00885556387795), received between Jun 23, 2019 and Aug 10, 2025 — classified as 5 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Break” (23 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, ONE 1.8/2.4 MM DOUBLE-ENDED DRILL GUIDE BROKE AFTER IT WAS PLACED IN THE PLATE HOLE AND AN ATTEMPT WAS MADE TO REPOSITION IT. NO PIECE FELL INTO THE PATIENT'S WOUND. THE PROCEDURE WAS RESUMED WITHOUT ANY SURGICAL DELAY USING A SN BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22767945 ↗
• MalfunctionJul 13, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE BROKE DURING DRILLING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22491103 ↗
• MalfunctionDec 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, A 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE BECAME BOUND ON THE DRILL AND BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. A NON-SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860485 ↗
• MalfunctionMar 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE 2.4 SIDE OF THE 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE BROKE OFF DURING USE. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894359 ↗
• MalfunctionDec 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE THREADED TIP OF AN 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE UNSCREWED FROM THE HANDLE WHILE THE SURGEON WAS DRILLING THROUGH IT. SURGERY WAS COMPLETED WITH A BACK UP S+N DEVICE WITH MINIMAL DELAY AND NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282181 ↗
• MalfunctionOct 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING USE, ONE END OF THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE WITH THE BASE OF THE DRILL INSIDE OF IT. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17862604 ↗
• MalfunctionApr 12, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE 1.8MM END OF A 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE BROKE OFF, NO PIECE FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728300 ↗
• MalfunctionNov 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING USE, A 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE BROKE. HOWEVER, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACKUP DEVICE. THE PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785868 ↗
• MalfunctionOct 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT A 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE BROKE OFF. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15675049 ↗
• MalfunctionOct 22, 2022Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP AND INSPECTION, THE 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE HAD A BROKEN TISSUE SLEEVE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656077 ↗
• MalfunctionMay 21, 2022Break; Fracture; Physical Resistance/Sticking; Break; Fracture; Physical Resistance/Sticking

  IT WAS REPORTED THAT, A 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE BROKE IN THE GUIDE AND IS STUCK. NEED A NEW DRILL GUIDE. IT IS UNKNOWN WHEN THE EVENT HAPPENED OR IF THERE WAS ANY DELAY NOR INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466948 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING FIELD INSPECTION, IT WAS FOUND THAT THE 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE WAS BROKEN. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725208 ↗
• MalfunctionMar 10, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE BROKE INSIDE DRILL. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13724973 ↗
• MalfunctionOct 8, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE END OF A 1.8/2.4MM DOUBLE-ENDED GUIDE BROKE OFF DURING PROCEDURE. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, WITHOUT ANY DELAY. INSTRUMENTS WERE OUTSIDE THE PATIENT. NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12597933 ↗
• MalfunctionAug 19, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF A 1.8/2.4 MM DOUBLE-ENDED DRILL GUIDE BROKE OFF IN GUIDE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12343159 ↗
• MalfunctionJul 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, A 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE BROKE INSIDE THE PATIENT. ALL PIECES WERE RECOVERED FROM THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12124862 ↗
• MalfunctionJun 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE TIP OF A 1.8/2.4MM EVOS MINI DOUBLE-ENDED DRILL GUIDE BROKE OUTSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042728 ↗
• MalfunctionJun 18, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THAT A1.8/2.4MM DOUBLE-ENDED DRILL GUIDE IS BENT. INCIDENT OCCURRED DURING SET UP OR INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022887 ↗
• MalfunctionMay 13, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, UPON DRILLING THROUGH THE 1.8 SIDE OF THE 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE, THE BASE OF THE SHAFT BENT, MAKING IT NO LONGER USABLE. A SMITH AND NEPHEW BACKUP DEVICE WAS AVAILABLE. NO INJURY OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11822311 ↗
• MalfunctionApr 28, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A SET UP OR INSPECTION DRILL GUIDE BENT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742422 ↗
• MalfunctionApr 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER PROCEDURE THE DRILL BIT GOT STUCK IN DRILL GUIDE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. PATIENT INJURIES WERE NOT REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742420 ↗
• MalfunctionApr 27, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, WHEN THE SURGEON INSERTED THE DRILL INTO THE 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE, THE DRILL BOUND-UP IN THE DRILL GUIDE AND BROKE OFF. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735889 ↗
• InjuryApr 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, A 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE (CASE: (B)(4)) BROKE OFF, AND THE DRILL BROKE OFF INSIDE THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE (CASE: (B)(4)). INSTRUMENTS WERE INSIDE OF THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS DELAY OF LESS THAN OR EQUAL TO 30MINS. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11730134 ↗
• InjuryApr 23, 2021Break; Break

  IT WAS REPORTED THAT A DRILL BIT BROKE WITHIN THE GUIDE AND STUCK IN THE 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE DURING PROCEDURE. THIS OCCURRED WHILE USING THE DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720734 ↗
• MalfunctionApr 18, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A 1.8/2.4MM DOUBLE-ENDED DRILL GUIDE WAS BENT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683480 ↗