EVOS 71175077Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885556636077), received between Jul 21, 2020 and Mar 5, 2025 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, ONE (1) EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER BROKE WHILE TIGHTENING DOWN A SCREW. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT, WITH SURGEON'S HAND. THIS DID NOT CAUSE ANY INJURY TO PATIENT. 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 21531892 ↗
• MalfunctionDec 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION, WHILE INSERTING THE SCREW WITH ONE (1) EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER, THE HEAD BROKE OFF A SMALL PIECE DURING A DISTAL HUMOROUS ORIFICE PROCEDURE. ALL THE BROKEN PIECES WERE SUCCESSFULLY RECOVERED BY HAND. 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 20952160 ↗
• MalfunctionAug 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING PLATE PROCEDURE, THE TIP OF AN EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER BROKE OFF. NO PIECES FELL INTO 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 19991336 ↗
• MalfunctionJan 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE MID SHAFT OF AN EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER BROKE IN HALF WHILE TRYING TO USE TO BEND PLATE, BROKE EXTERNAL TO PATIENT, NO PIECES FELL IN WOUND, ALL PIECES ACCOUNTED FOR. 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 18543502 ↗
• MalfunctionSep 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF THE EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER BROKE. THE PATIENT WAS NOT HARMED. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843954 ↗
• MalfunctionMar 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA PLATING SURGERY, THE TIP OF ONE (1) EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER BROKE OFF WHILE IN USE. 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 16620921 ↗
• MalfunctionMar 26, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE TINES OF SIX EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER ARE ROUNDED OFF. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925079 ↗
• MalfunctionFeb 17, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE T8 FIXED HANDLE DRIVER WAS STRIPPED. 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 13549293 ↗
• InjurySep 24, 2021Break; Break

  IT WAS REPORTED DURING A TRAUMA PROCEDURE, THAT THE TIP OF A EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER SHEARED OFF. ALL PIECES WERE RECOVERED, PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE, NO DELAY REPORTED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12529861 ↗
• MalfunctionMay 31, 2021Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE T8 FIXED HANDLE DRIVER BROKE OUTSIDE THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907610 ↗
• MalfunctionMay 21, 2021Connection Problem; Material Deformation; Naturally Worn; Connection Problem; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, AN EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER WAS WORN; HENCE, IT WAS UNABLE TO HOLD THE SCREW. SURGERY WAS RESUMED, WITHOUT ANY SIGNIFICANT DELAY, WITH AN AVAILABLE SMITH AND NEPHEW BACK UP DEVICE; THEREFORE, PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861513 ↗
• MalfunctionMay 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SURGERY, THE HEAD OF AN EVOS SMALL FIXED HANDLE LINEAR DRIVER WAS NOTICED DAMAGED AND NOT ALLOWING THE DEVICE TO HOLD THE SCREW CORRECTLY. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED AS A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810098 ↗
• MalfunctionFeb 18, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THESE SCREWDRIVERS ARE WORN DOWN. THIS WAS DISCOVERED DURING INSPECTION IN CPD, THIS DID NOT HAPPEN DURING SURGERY. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345938 ↗
• MalfunctionFeb 14, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT, THE DURING AN UNKNOWN PROCEDURE THE EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER WAS NOTICED WORN SO DID NOT SCREW IN THE SCREW EFFICIENTLY. 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 11326142 ↗
• InjuryDec 6, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE T8 FIXED HANDLE DRIVER IS STRIPPING THE SCREW HEAD. THE EVENT OCCURRED DURING USE, WITH INSTRUMENTS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE, USING A MODULAR SCREWDRIVER. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10956308 ↗
• MalfunctionNov 11, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A EVOS SMALL TRAUMA CASE, THE DRIVER HAS BECOME STRIPPED AND IS HAVING DIFFICULTY CAPTURING SCREWS. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10824482 ↗
• MalfunctionAug 13, 2020Defective Device; Incomplete or Inadequate Connection; Defective Device; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING AN ANKLE PROCEDURE THE EVOS SMALL T8 FIXED HANDLE LINEAR DRIVER GOT STRIPPED AND DOES NOT ENGAGE THE SCREW HEAD PROPERLY. THIS HAPPENED DURING USE INSIDE THE PATIENT. SURGEON HAD BACKUP S&N DRIVERS TO USE IN ITS PLACE. NO DELAY REPORTED. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. 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 Information

  MAUDE report 10404748 ↗
• MalfunctionAug 7, 2020Degraded; Degraded

  IT WAS REPORTED THAT BEFORE SURGERY WHILE GETTING READY FOR THE CASE THE SCREW DRIVER WAS FOUND TO BE STRIPPED. IT IS UNKNOWN IF THERE WAS A DELAY O HOW THE PROCEDURE WAS FINISHED. NO INJURIES REPORTED AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 10380674 ↗
• MalfunctionJul 21, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE DOCTOR WAS TIGHTENING A SCREW, THE TIP OF THE SCREWDRIVER STARTED TO SKIP AND NEEDS TO BE REPLACED. THE PATIENT WASN¿T AFFECTED AND IT DELAYED SURGERY JUST A MINUTE. A SMITH AND NEPHEW BACKUP DRIVER WAS USED TO FINISH THE PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10304695 ↗