EVOS 71174934Recalls & reported problems

Summary

The FDA's MAUDE database contains 149 adverse event reports that list this exact device (DI 00885556387993), received between Dec 17, 2018 and Jun 29, 2026 — classified as 15 injuries, 134 malfunctions.

The most frequently reported specific device problem is “Break” (81 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 149 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Break

  IT WAS REPORTED THAT, DURING A INTERNAL FIXATION SURGERY, ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE HOUSING WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25661895 ↗
• MalfunctionMay 3, 2026Break

  IT WAS REPORTED THAT, DURING AN EVOS MINI FRAG SURGERY, THE DRILL BIT GOT STUCK IN ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND BROKE THE GUIDE WHEN TRYING TO REMOVE IT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062992 ↗
• MalfunctionApr 28, 2026Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION, THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE OFF WHEN IT WAS DRILLING. ADDITIONALLY, BOTH SHORT DEPTH GAUGE 2.4MM/2.7MM SCREWS ARE BENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013598 ↗
• MalfunctionApr 14, 2026Break

  IT WAS REPORTED THAT, DURING AN ANKLE ORIF SURGERY, WHILE DRILLING FOR A LAG SCREW, ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE WHILE APPLYING PRESSURE TO THE BONE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873218 ↗
• MalfunctionFeb 17, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, BONE CAUSED A DRILL TO JAM AND TWO (2) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE SNAPPED. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY OR HOW THE PROCEDURE WAS RESUMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363980 ↗
• MalfunctionFeb 13, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE 2.0/2.7 MM DOUBLE-ENDED DRILL GUIDE BROKE. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333657 ↗
• MalfunctionJan 29, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY WHILE DRILLING, THE END OF ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE OFF OUTSIDE OF PATIENT. IT WAS CONFIRMED THAT NO FRAGMENTS FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24216513 ↗
• MalfunctionJan 9, 2026Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A INTERNAL FIXATION SURGERY, THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE OFF. IT IS UNKNOW IF ANY PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028365 ↗
• MalfunctionAug 28, 2025Fracture; Separation Failure; Detachment of Device or Device Component; Fracture; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, THE DRILL SLEEVE OF THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE SNAPPED OFF AND THE DRILL BIT WAS STUCK IN THE SLEEVE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, 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 22919675 ↗
• MalfunctionAug 19, 2025Separation Failure; Detachment of Device or Device Component; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, WHEN THE SURGEON ATTEMPTED TO DRILL THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE WITH A 2.7 DRILL, IT BECAME JAMMED IN THE GUIDE AND THE GUIDE TUBE SEPARATED FROM THE HANDLE. THE DRILL COULD NOT BE EXTRACTED FROM THE GUIDE. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22837911 ↗
• MalfunctionJun 5, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE END OF ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE. THE BROKEN END WAS DISPOSED OF. ALL BROKEN PIECES WERE EASILY REMOVED FROM WOUND MANUALLY. 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 22155753 ↗
• MalfunctionMay 15, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SURGERY, THE END OF ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE OFF AND CAME APART. THERE WAS NO DRILL BIT STUCK INSIDE, AND NOTHING WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT ANY SURGICAL 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 22025252 ↗
• MalfunctionMay 13, 2025Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT DURING SURGERY ONE (1) DRILL GOT STUCK IN ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND THE DRILL GUIDE SLEEVE BROKE APART FROM THE DRILL GUIDE HANDLE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010177 ↗
• MalfunctionAug 22, 2024Solder Joint Fracture; Separation Failure; Detachment of Device or Device Component; Solder Joint Fracture; Separation Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CLAVICLE INTERNAL FIXATION, A DRILL SEIZED IN THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE WITH SUCH TORQUE THAT THE 2.0 CANNULA BROKE THE WELD AND UNSCREWED FROM THE GUIDE. THE PROCEDURE WAS PERFORMED, AFTER NO DELAY, WITH A SN BACK-UP DEVICE PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031503 ↗
• MalfunctionMay 2, 2024Break; Break

  IT WAS REPORTED THAT DURING INTERNAL FIXATION SURGERY ONE DRILL (UNKN EVOS PLATING INSTR) BROKE IN THE 2.0 SECTION OF THE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE. IT BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19233619 ↗
• MalfunctionMar 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE SNAPPED OFF OUTSIDE OF 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 18950089 ↗
• MalfunctionDec 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA CASE, A 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248674 ↗
• MalfunctionNov 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE WAS BROKEN WHEN SURGEON DRILLED THROUGH THE GUIDE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, 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 18121621 ↗
• MalfunctionNov 13, 2023Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE DRILL BOUND UP AND BROKE INSIDE ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE. 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 18120555 ↗
• MalfunctionNov 13, 2023Fracture; Mechanical Jam; Fracture; Mechanical Jam

  IT WAS REPORTED THAT DURING A ORIF CLAVICLE, THE 2.0 DRILL BECOME STUCK IN THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND SNAPPED OFF. NO PIECES FELL IN PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18119647 ↗
• MalfunctionOct 30, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING, AN ORIF OF AN ANKLE FRACTURE, A DRILL GOT STUCK IN A 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND BROKE OFF. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NOTHING WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031790 ↗
• MalfunctionOct 27, 2023Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, A DRILL BUT GOT STUCK IN ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND IT BROKE. DEVICE WAS THROWN AWAY IN SHARPS BIN SO IT WASN'T ABLE TO OBTAIN. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW THE PROBLEM WAS SOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026226 ↗
• MalfunctionOct 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT A 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE THE DRILL INSIDE OF THE GUIDE WHILE DRILLING INTO A CLAVICLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000051 ↗
• 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 17862876 ↗
• MalfunctionSep 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, ONE OF THE ATTACHMENTS ON A 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE BROKE OFF. THE DRILL ATTACHED TO GUIDE, BECAME STUCK AND PULLED GUIDE OUT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH AN UNKNOWN CHANGE IN THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17744132 ↗