EVOS 71175073Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885556636053), received between Sep 10, 2020 and Jan 9, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE SHAFT OF A EVOS SM 2.5MM TAPERED HEX DR SHAFT-SHORT SNAPPED WITHIN THE HANDLE. 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 24023821 ↗
• MalfunctionMar 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF ONE (1) EVOS SM 2.5MM TAPERED HEX DR SHAFT-SHORT BROKE WHEN TRYING TO INSERT THE SCREW. THE PROCEDURE WAS COMPLETED WITHOUT 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 21619028 ↗
• MalfunctionNov 17, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A EVOS SM 2.5MM TAPERED HEX DR SHAFT-SHORT WAS BROKEN. SURGERY WAS RESUMED, WITHOUT A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH A COMPETITOR DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833459 ↗
• 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 11346040 ↗
• MalfunctionNov 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY THE 2.5MM HEX DRIVER SHAFT SHORT DRIVERS ARE GETTING STRIPPED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10849948 ↗
• MalfunctionNov 17, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY THE 2.5MM HEX DRIVER SHAFT SHORT DRIVERS ARE GETTING STRIPPED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10849947 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SM 2.5MM TAPERED HEX 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 10795544 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SM 2.5MM TAPERED HEX 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 10795514 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SM 2.5MM TAPERED HEX 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 10795506 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SM 2.5MM TAPERED HEX 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 10795497 ↗
• MalfunctionNov 5, 2020Connection Problem; Material Deformation; Naturally Worn; Connection Problem; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE EVOS SM 2.5MM TAPERED HEX 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 10795484 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SM 2.5MM TAPERED HEX 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 10793093 ↗
• MalfunctionNov 5, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE EVOS SM 2.5MM TAPERED HEX 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 10792983 ↗
• MalfunctionNov 5, 2020Material Deformation; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE EVOS SM 2.5 MM TAPERED HEX 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

  MAUDE report 10792810 ↗
• MalfunctionNov 4, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE HEX DRIVER IS STRIPPED AND NEEDS TO BE REPLACED. FAULT IN DEVICE WAS NOTICED DURING PROCEDURE, WHILE INSTRUMENTS WERE OUTSIDE THE PATIENT. PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO SURGICAL DELAY OF 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 10788254 ↗
• InjuryNov 2, 2020Difficult to Insert; Defective Device; Difficult to Insert; Defective Device

  IT WAS REPORTED THAT DURING TREATMENT THE EVOS SM 2.5MM TAPERED HEX DR SHAFT-SHORT WAS BEING USED AND THE TIP OF THE DEVICE WAS SLIPPING ON THE HEAD OF THE MULTIPLE SCREWS. THERE WAS NO DELAY AND NO PATIENT HARMED. THERE WAS ANOTHER SN PRODUCT (EVOS SM 2.5MM TAPERED HEX DR SHAFT-LONG) AVAILABLE TO USE. 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 10775578 ↗
• MalfunctionOct 14, 2020Defective Device; Material Deformation; Defective Device; Material Deformation

  IT WAS REPORTED THAT THE EVOS SM 2.5MM TAPERED HEX DR SHAFT-SHORT WAS FOUND TO BE STRIPPED. IT IS UNKNOWN IF THERE WAS ANY CASE INVOLVED AND IF IT CAUSED A DELAY OR A BACK UP WAS NEEDED. NO INJURIES 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 10681786 ↗
• MalfunctionSep 10, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION PROCESS THE FOLLOWING DEVICES WERE FOUND TO BE STRIPPED: EVOS SM 2.5MM FIXED HANDLE LINEAR HEX DRIVER ((B)(4)), EVOS SM 2.5MM TAPERED HEX DRIVER SHAFT-SHORT ((B)(4)), AND EVOS SM 2.5MM TAPERED HEX DRIVER SHAFT-LONG ((B)(4)). THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10514060 ↗