EVOS 71175041Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885556636404), received between Jul 9, 2020 and Dec 2, 2025 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY THE TIP OF ONE (1) EVOS 2.5MM X 3.5MM DRILL GUIDE TWISTED OFF WHILE THE SURGEON TRIED TO DRILL THROUGH IT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP DEVICE. NO ADDITIONAL ANESTHETIC WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23700953 ↗
• MalfunctionSep 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN ANKLE INTERNAL FIXATION SURGERY, ONE (1) EVOS 2.5MM X 3.5MM DRILL GUIDE BROKE/CAME LOOSE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAT 30 MINUTES, WITH 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 22963602 ↗
• MalfunctionApr 1, 2024Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT, DURING A CLAVICLE ORIF, THE EVOS 2.5MM X 3.5MM DRILL GUIDE CAME APART WHILE DRILLING INTO BONE. THE EVOS SMALL 2.5MM DRILL W/AO QC SHORT WAS ALSO STUCK IN THE GUIDE. SURGERY WAS PERFORMED AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19012826 ↗
• MalfunctionOct 19, 2022Break; Break

  IT WAS REPORTED THAT ONE EVOS 2.5MM X 3.5MM DRILL GUIDE HAD ONE OF THE GUIDES MISSING. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMS THE 2.5MM SIDE OF THE DEVICE IS BROKEN OFF, RENDERING THE DEVICE INOPERABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15636038 ↗
• MalfunctionJul 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE EVOS 2.5MM X 3.5MM DRILL GUIDE WAS DETACHED. THE CYLINDRICAL TUBE ON EITHER END UNTHREADED FROM THE GUIDE ITSELF. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING THE NON-VARIABLE ANGLE DRILL GUIDE THAT WAS IN THE SAME SET. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911838 ↗
• MalfunctionNov 22, 2021Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR A TRAUMA SURGERY, IT WAS OBSERVED THAT AN EVOS 2.5MM X 3.5MM DRILL GUIDE WAS BROKEN. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT 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 12852949 ↗
• InjurySep 3, 2021Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, ONE EVOS 2.5MM X 3.5MM DRILL GUIDE BROKE INSIDE THE PATIENT. NO HEALTH CONSEQUENCES WERE REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422582 ↗
• MalfunctionSep 3, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE DRILL BIT GOT STUCK IN THE EVOS 2.5MM X 3.5MM DRILL GUIDE AND BROKE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12421637 ↗
• MalfunctionJun 18, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE EVOS 2.5MM X 3.5MM DRILL GUIDE COMPLETELY DETACHED FROM GUIDE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022895 ↗
• MalfunctionJun 18, 2021Break; Break

  IT WAS REPORTED THAT THE HEAD OF A 2.5MM FIXED HANDLE HEX DRIVER ((B)(4)) IS STRIPPED AND THAT THE SLEEVE OF A EVOS 2.5MM X 3.5MM DRILL GUIDE ((B)(4)) IS BROKE OFF. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022891 ↗
• MalfunctionMay 24, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT 2 EVOS 2.5 MM X 3.5 MM DRILL GUIDE WERE BENT AND DRILL CANNOT FIT THROUGH. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872861 ↗
• MalfunctionMay 24, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT 2 EVOS 2.5 MM X 3.5 MM DRILL GUIDE WERE BENT AND DRILL CANNOT FIT THROUGH. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11872859 ↗
• MalfunctionJan 6, 2021Crack; Crack

  IT WAS REPORTED THAT, AN EVOS DRILL GUIDE WAS STUCK AND IT COULD NOT BE UNSCREWED FROM THE GUIDE. INCIDENT OCCURRED DURING PROCEDURE WITH INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. HOWEVER, DURING THE DEVICE EVALUATION, IT WAS REPORTED THAT THE ATTACHMENT POST ON THE DEVICE WAS FRACTURED OFF. 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 11123647 ↗
• MalfunctionAug 6, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO SURGERY THE HOOK ON END OF DEPTH GAUGE WAS NOTICED BROKEN OFF. THE DRILL BIT BENT INSIDE THE DRILL GUIDE CAUSING THE DRILL GUIDE TO BE BENT ITSELF. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10374828 ↗
• MalfunctionJul 27, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION WAS NOTICED THAT THE EVOS 2.5MM X 3.5MM DRILL GUIDE IS SEEN TO BE BENT AND NEEDS TO BE REPLACED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10330367 ↗
• InjuryJul 9, 2020Mechanical Problem; Difficult to Remove; Defective Device; Mechanical Problem; Difficult to Remove; Defective Device

  IT WAS REPORTED THAT DURING SURGERY (OPEN REDUCTION AND INTERNAL FIXATION OF THE FOREARM FRACTURE) THE 2.5MM DRILL BIT WAS GETTING CAUGHT IN THE 2.5MM SIDE OF DRILL GUIDE; SURGEON WAS HAVING TROUBLE REMOVING DRILL FROM GUIDE. SURGEON USED ANOTHER 2.5 DRILL GUIDE THAT WAS ASSEMBLED WITH OTHER COMPONENTS OF THE SYSTEM. THIS HAPPENED DURING USE INSIDE THE PATIENT. NO DELAY REPORTED. 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; No Known Impact Or Consequence To Patient

  MAUDE report 10254563 ↗