EVOS 71174984Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885556500491), received between Apr 17, 2020 and Mar 24, 2026 — classified as 2 injuries, 16 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. 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.

• MalfunctionMar 24, 2026Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) T6 LINEAR DRIVER SHAFT W/ AO QC BROKE. 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 24678655 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE END OF (1) ONE T6 LINEAR DRIVER SHAFT W/ AO QC BROKE DURING THE CASE. IN ADDITION, ANOTHER T6 LINEAR DRIVER SHAFT W/ AO QC WOULD NOT CAPTURE THE SCREW. FURTHERMORE, (2) TWO T6 HOLDING SLEEVE NEED REPLACEMENT DUE TO UNKNOWN REASONS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT 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 20756487 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) T6 LINEAR DRIVER SHAFT W/ AO QC BROKE. IT IS UNKNOWN HOW THE TREATMENT WAS COMPLETED AND IF ANY DELAY WAS CAUSED DUE TO THIS INCIDENT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643451 ↗
• MalfunctionMar 26, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHILE TIGHTENING A SCREW WITH A T6 LINEAR DRIVER SHAFT W/ AO QC, THE TIP OF THE DRIVER 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 16616861 ↗
• MalfunctionFeb 23, 2023Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF A T6 LINEAR DRIVER SHAFT W/ AO QC WAS BROKEN. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH 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 16432666 ↗
• MalfunctionFeb 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE TIP OF THE T6 LINEAR DRIVER SHAFT W/ AO QC BROKE. THE ITEM WAS DISCARDED BY HOSPITAL STAFF BEFORE IT COULD BE RETRIEVED. NO PIECES ENTERED TO THE PATIENT. SURGERY WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED, OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13418982 ↗
• InjuryDec 27, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE T6 LINEAR DRIVER SHAFT W/ AO QC BROKE INSIDE PATIENT. IT WAS VERIFIED THAT THE BROKEN PIECE DID NOT REMAIN IN THE PATIENT. SURGERY WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, USING A BACK-UP DEVICE. PATIENT WAS NOT INJURED BEYOND THE ISSUE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087842 ↗
• MalfunctionJun 8, 2021Physical Resistance/Sticking; Thickening of Material; Physical Resistance/Sticking; Thickening of Material

  IT WAS REPORTED THAT DURING TRAUMA PROCEDURE, THE HOLDING SLEEVE OF A T6 LINEAR DRIVER SHAFT W/ AO QC GOT STUCK. THERE WAS A REPORTED DELAY OF FEWER THAN 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. AFTER VISUAL INSPECTION OF THE REPORTED DEVICE IT WAS FOUND THAT THE THREADS ON THE DEVICE WAS FOUND TO BE STRIPPED, RENDERING THE DEVICE INOPERABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962674 ↗
• MalfunctionMar 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING INSPECTION, THE SPLINES OF THE DRIVERS WERE BENT/TWISTED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431084 ↗
• MalfunctionFeb 14, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE METAL AT TIP ON THE LINEAR DRIVER SHAFT W/ AO QC IS WEAKENING AND FLUTES ARE STARTING TO SPIRAL. IT IS UNKNOWN IF THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT; THEREFORE, PATIENT INVOLVEMENT COULD NOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326210 ↗
• MalfunctionFeb 14, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT AFTER PROCEDURE NOTICED THAT THE THREADS WERE TWISTED. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326200 ↗
• MalfunctionFeb 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER PROCEDURE THE THREADS ON DISTAL TIP FOR THE T6 LINEAR DRIVER SHAFT W/ AO QC WERE FOUND TWISTED. NO BACK UP NEEDED. NO DELAY INVOLVED. 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

  MAUDE report 11284697 ↗
• MalfunctionFeb 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT AFTER PROCEDURE THE THREADS ON DISTAL TIP FOR THE T6 LINEAR DRIVER SHAFT W/ AO QC WERE FOUND TWISTED. NO BACK UP NEEDED. NO DELAY INVOLVED. 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

  MAUDE report 11284695 ↗
• InjuryJan 19, 2021Break; Break

  IT WAS REPORTED DURING THE PROCEDURE THAT THE DRIVER HEAD SNAPPED OFF DURING TIGHTENED OF A SCREW. ALL PIECES WERE RECOVERED. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MINUTES AND IT WAS USE A BACKUP FROM SMITH & NEPHEW TO FINISHED THE SURGERY. THE SURGEON DID NOT BLAME THE DEVICE AND HE WAS SATISFIED WITH THE SURGICAL OUTCOME. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197623 ↗
• MalfunctionJan 6, 2021Material Twisted/Bent; Naturally Worn; Material Twisted/Bent; Naturally Worn

  IT WAS REPORTED THAT, AFTER SURGERY, T6 LINEAR DRIVER SHAFT DEVICE WAS TWISTED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11125939 ↗
• MalfunctionOct 19, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE LINEAR DRIVER WAS FOUND BENT. IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10702582 ↗
• MalfunctionJul 22, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY, THE T6 LINEAR DRIVER SHAFT W/ AO QC BENT/WARPED WHEN THE DOCTOR WAS INSERTING THE LOCKING SCREW. THERE WAS A S+N BACKUP DEVICE AVAILABLE TO CONTINUE THE PROCEDURE WITHOUT DELAYS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10307711 ↗
• MalfunctionApr 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE PROCEDURE DEVICE PRESENTED UNSPECIFIED FUNCTIONAL FAILURE. NO HARM TO PATIENT OR STAFF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9975370 ↗