EVOS 71175078Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00885556636084), received between May 31, 2019 and Mar 26, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, THE TIP OF EVOS SMALL T8 TAPERED DR SHAFT - SHORT BROKE AS SCREW WAS INSERTED. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. 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 21696476 ↗
• MalfunctionMar 20, 2025Break; Break

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, A EVOS SMALL T8 TAPERED DR SHAFT - SHORT BROKE WHILE TRYING TO INSERT A SCREW. NO PIECES FELL INTO PATIENT. THERE WAS NO 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 21654028 ↗
• MalfunctionNov 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY, WHEN PUTTING A SCREW INTO A LATERAL FIBULAR PLATE, THE TIP OF ONE (1) EVOS SMALL T8 TAPERED DR SHAFT - SHORT BROKE OFF. TWO MM OF THE TIP BROKE. NOTHING WAS LEFT IN 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 20773304 ↗
• MalfunctionAug 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION PROCEDURE, UPON ENTERING A 2.7MM SCREW INTO PLATE, THE TIP OF AN EVOS SMALL T8 TAPERED DR SHAFT - SHORT CHIPPED. 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 19937900 ↗
• MalfunctionDec 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE TIP OF THE EVOS SMALL T8 TAPERED DR SHAFT - SHORT BROKE WHILE TIGHTENING A SCREW IN AN EVOS CLAVICLE PLATE. THE DRIVER BROKE DURING FINAL HAND TIGHTENING OF AN EVOS 2.7 LOCKING SCREW. NO PIECE OF THE DRIVER FELL INTO THE PATIENT'S ANATOMY AS THE TIP REMAINED LODGED IN THE SCREW HEAD. THE SURGEON REMOVED THE BROKEN DRIVER TIP PIECE FROM THE SCREW HEAD. THE SURGERY WAS COMPLETED WITH AN S+N BACKUP DEVICE AND THERE WAS NO SURGERY DELAY. X-RAY FLUOROSCOPY WAS CONFIRMED CLEAR BY THE SURGEON. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326900 ↗
• MalfunctionNov 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A EVOS SMALL T8 TAPERED DR SHAFT - SHORT BROKE DURING USE. IT IS UNKNOWN HOW PROCEDURE WAS FINISHED AND IF THERE WAS A DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172546 ↗
• MalfunctionNov 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, THE PIT BROKE OFF OF ONE (1) EVOS SMALL T8 TAPERED DR SHAFT - SHORT WHILE TIGHTENING THE SCREW. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18084741 ↗
• MalfunctionApr 15, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING PROCEDURE THE SURGEON NOTED THAT THE T8 SCREWDRIVER SHAFT SHORT STRIPPED. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11671469 ↗
• MalfunctionApr 11, 2021Loose or Intermittent Connection; Material Deformation; Loose or Intermittent Connection; Material Deformation

  IT WAS REPORTED THAT DURING USE, FOR A EVOS SMALL T8 TAPERED DR SHAFT - SHORT IT WAS NOTED THAT THE DRIVER HAS BECOME ROUNDED AND DOES NOT CAPTURE SCREW. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646839 ↗
• MalfunctionApr 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING USE, FOR A EVOS SMALL T8 TAPERED DR SHAFT - SHORT IT WAS NOTED THAT THE DRIVER HAS BECOME ROUNDED AND DOES NOT CAPTURE SCREW. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646838 ↗
• MalfunctionMar 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS FOUND THAT THE EVOS SMALL T8 TAPERED DR SHAFT - SHORT IS STRIPPED. INSTRUMENTS INSIDE PATIENT ITEM WAS DISCARDED. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431053 ↗
• MalfunctionFeb 18, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THIS SCREWDRIVER WAS 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 11345931 ↗
• MalfunctionDec 9, 2020Material Deformation; Material Deformation

  IT WAS REPORTED DURING THE PROCEDURE THAT THE SCREW DRIVERS ARE STRIPPED AND NEED TO BE REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978892 ↗
• MalfunctionDec 9, 2020Material Deformation; Material Deformation

  IT WAS REPORTED DURING THE PROCEDURE THAT THE SCREW DRIVERS ARE STRIPPED AND NEED TO BE REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10978790 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SMALL T8 TAPERED DRIVER SHAFT-SHORT HAS BECOME WORN OUT AND IS HAVING DIFFICULTY CAPTURING THE SCREWS. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10795594 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SMALL T8 TAPERED DRIVER SHAFT-SHORT HAS BECOME WORN OUT AND IS HAVING DIFFICULTY CAPTURING THE SCREWS. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10795572 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SMALL T8 TAPERED DRIVER SHAFT-SHORT HAS BECOME WORN OUT AND IS HAVING DIFFICULTY CAPTURING THE SCREWS. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10795534 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SMALL T8 TAPERED DRIVER SHAFT-SHORT HAS BECOME WORN OUT AND IS HAVING DIFFICULTY CAPTURING THE SCREWS. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10795521 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SMALL T8 TAPERED DRIVER SHAFT-SHORT HAS BECOME WORN OUT AND IS HAVING DIFFICULTY CAPTURING THE SCREWS. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10795493 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SMALL T8 TAPERED DRIVER SHAFT-SHORT HAS BECOME WORN OUT AND IS HAVING DIFFICULTY CAPTURING THE SCREWS. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10793105 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SMALL T8 TAPERED DRIVER SHAFT-SHORT HAS BECOME WORN OUT AND IS HAVING DIFFICULTY CAPTURING THE SCREWS. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10792984 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SMALL T8 TAPERED DRIVER SHAFT-SHORT HAS BECOME WORN OUT AND IS HAVING DIFFICULTY CAPTURING THE SCREWS. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10792834 ↗
• MalfunctionJun 16, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY, THE SCREW HEAD INTERFACE BENT OR TWISTED INSIDE THE PATIENT, WHEN INSERTING A 2.7MM LOCKING SCREW, DUE TO THIS THE CONTROLLER CAN NO LONGER BE USED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. BACKUP FROM SMITH&NEPHEW WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE 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 10160072 ↗
• MalfunctionJun 16, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY THE SHORT T8 POWER DRIVER HEAD TWISTED WHILE INSERTING SCREW (INSIDE THE PATIENT). THE PROCEDURE WAS COMPLETED WITHOUT DELAY. BACKUP FROM SMITH&NEPHEW WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED AT THE MOMENT. 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 10159971 ↗
• MalfunctionMay 31, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE HEAD OF THE SCREW DRIVER SNAPPED OFF. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY. NO INJURY OR PATIENT IMPACT HAS BEEN CONFIRMED YET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8660067 ↗