EVOS 71174924Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00885556387498), received between May 20, 2020 and Feb 13, 2024 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY, THE 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE TUBE BENT SLIGHTLY NOT ALLOWING THE DRILL BIT TO PASS. IT WAS TRIED TO BEND BACK BUT IT BROKE. NO PIECES FELL INSIDE THE 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 18693204 ↗
• MalfunctionJun 5, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE BROKE OUTSIDE OF THE PATIENT, AND NO PIECES FELL INSIDE. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH 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 14599425 ↗
• MalfunctionApr 28, 2022Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE BROKE. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14236939 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, AN EVOS 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE BROKE OUTSIDE THE PATIENT. NO PIECES FELL INTO 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 12911400 ↗
• InjurySep 1, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE BIT OF A 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE GOT STUCK IN THE 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE AND BROKE. THE DRILL BIT BROKE WHILE DRILLING INSIDE THE PATIENT. ONE PIECE WAS STUCK IN THE DRILL GUIDE AND THE OTHER WAS IN THE AO CONNECTOR OF THE DRILL. THE TWO PIECES WERE THEN MATCHED TO EACH OTHER AND X-RAYS WERE TAKEN TO CONFIRM THERE WERE NO REMAINING PIECES. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408526 ↗
• MalfunctionJun 18, 2021Crack; Crack

  IT WAS REPORTED THAT A DEPTH GAUGE FOR 2.0MM SCREWS (CASE-2021-00057520-1) IS BENT AND THE SLEEVE OF A 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE (CASE-2021-00057520-2) IS CRACKED AT THE BOTTOM. INCIDENT OCCURRED DURING SET UP OR INSPECTION; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12022888 ↗
• MalfunctionMay 10, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, IT WAS UNABLE TO PLACE 1.5 DRILL THROUGH 1.5 OPENING IN DRILL GUIDE, BECAUSE THE 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE WAS SLIGHTLY BENT. AS THIS WAS NOTICED DURING INSPECTION AFTER WASH, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803311 ↗
• MalfunctionMay 10, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, AFTER THE DEVICE WAS CLEANED IN CSP, WHEN TESTING THE 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE IT WAS NOTICED THAT THE DEVICE WAS SLIGHTLY BENT AND WOULD NOT GO THROUGH GUIDE SMOOTHLY. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803220 ↗
• MalfunctionApr 18, 2021Break; Break

  IT WAS REPORTED THAT A 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683477 ↗
• MalfunctionApr 11, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE SET UP OF AN UNSPECIFIED PROCEDURE, THE 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE IS BENT. PROCEDURE WAS FINISHED WITH A S&N BACKUP DEVICE WITHOUT SURGICAL DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646835 ↗
• MalfunctionMar 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE THE 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE BROKE. INSTRUMENTS OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11427196 ↗
• MalfunctionJan 27, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SURGERY, INSIDE THE PATIENT, THE DRILL GUIDE SLEEVE IS BENT SLIGHTLY, CAUSING THE DRILL TO GET STUCK WHEN BEING RETRACTED FROM THE GUIDE. THE PROCEDURE FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11240757 ↗
• MalfunctionDec 24, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT AFTER PROCEDURE THE DRILL BIT WILL NOT GO THROUGH THE 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE ANYMORE. THERE WAS NO DELAY. A S&N BACK UP WAS AVAILABLE IF NEEDED. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11070890 ↗
• MalfunctionOct 30, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS INITIALLY REPORTED THAT, AFTER AN UNKNOWN PROCEDURE, IT WAS NOTICED THAT THE 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE IS BEGINNING TO BEND. THE PATIENT WAS NOT INVOLVED AT THE MOMENT OF FINDING. THE PRELIMINARY RESULTS OF INVESTIGATION SHOW THAT THE 1.5 MILLIMETER DRILL SLEEVE HAS BEEN FRACTURED FROM THE DRILL GUIDE, RENDERING THE DEVICE INOPERABLE. THIS IS A REPORTABLE MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10764243 ↗
• MalfunctionMay 20, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY, THE 1.5/2.0MM DOUBLE-ENDED DRILL GUIDE WAS STICKING ON THE DRILL, AND WAS NOT GOING THROUGH SMOOTHLY. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY AND NO INJURY TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10077556 ↗