EVOS 71175068Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00885556635865), received between Mar 13, 2019 and Jun 5, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

1 other recall cover devices cleared under the same FDA submission (K162078); they may or may not involve this specific model.

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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2026Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, THE HOOK ON THE END OF ONE (1) EVOS SMALL 3.5MM DEPTH GAUGE LONG BROKE AND UNABLE TO MEASURE ACCURATELY. 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 25415627 ↗
• MalfunctionFeb 14, 2026Fracture

  IT WAS REPORTED THAT DURING AN ORIF PROCEDURE, THE HOOK TO THE EVOS SMALL 3.5MM DEPTH GAUGE LONG WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340902 ↗
• MalfunctionJul 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ORIF SURGERY, THE TIP OF ONE EVOS SMALL 3.5MM DEPTH GAUGE LONG SNAPPED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL 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 22628445 ↗
• MalfunctionApr 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, AN EVOS SMALL 3.5MM DEPTH GAUGE LONG BROKE IN SURGERY. IT IS UNKNOWN HOW THE SURGERY WAS COMPLETED OR IF THIS CAUSED A SURGICAL DELAY. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21915664 ↗
• MalfunctionNov 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION PROCEDURE, THE TIP OF ONE (1) EVOS SMALL 3.5MM DEPTH GAUGE LONG RIPPED OFF. NO PIECES GOT INSIDE OF 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 20641016 ↗
• InjuryNov 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TRAUMA SURGERY, THE TIP OF THE EVOS SMALL 3.5MM DEPTH GAUGE LONG DEVICE BROKE OFF. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. 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 15785867 ↗
• MalfunctionAug 10, 2022Fracture; Fracture

  IT WAS REPORTED THAT TIP OF A EVOS SMALL 3.5MM DEPTH GAUGE BROKE DURING WASH. AS THIS WAS NOTICED AFTER THE PROCEDURE, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200394 ↗
• MalfunctionJul 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE TIP HOOK OF AN EVOS SMALL 3.5MM DEPTH GAUGE LONG WAS OBSERVED TO BROKEN. THE CONTEXT IN WHICH THIS EVENT HAPPENED IS UNCLEAR. THE PROCEDURE WAS PERFORMED, WITH A DELAY OF LESS THAN 30 MIN, USING A S+N BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093888 ↗
• MalfunctionFeb 1, 2022Break; Break

  IT WAS REPORTED THAT DURING TREATMENT THE TIP OF EVOS SMALL 3.5MM DEPTH GAUGE LONG HAS BROKEN OFF AND WILL NO LONGER HOOK ONTO FAR CORTEX. THE TREATMENT WAS COMPLETED, WITHOUT DELAY, USING 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 13415389 ↗
• MalfunctionDec 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, A EVOS SMALL 3.5MM DEPTH GAUGE LONG BROKEN ((B)(4)) AND THE 2.5MM HEX LINEAR DRIVER SHAFT TIP BROKE DURING SCREW INSERTION ((B)(4)). DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908722 ↗
• MalfunctionMay 20, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE THIN PART OF THE METAL IN A EVOS SMALL 3.5MM DEPTH GAUGE LONG BENT AND WILL NOT MOVE. IN ADDITION, THE TIP OF THE DEVICE BROKE. AS THIS WAS NOTICED DURING SET UP, THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860072 ↗
• MalfunctionMay 20, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, THE TIP OF A LONG EVOS SMALL 3.5 DEPTH GUAGE GOT BENT AND BROKE OFF WHEN TRIED TO BEND BACK (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 11853540 ↗
• MalfunctionApr 20, 2021Break; Break

  IT WAS REPORTED THAT, FOR A EVOS SMALL 3.5MM DEPTH GAUGE LONG THE GAUGE WAS BROKEN. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693175 ↗
• MalfunctionApr 15, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT, DURING SURGERY, IT WAS NOTICED THAT THE TIP OF THE INNER SLEEVE ON THE DEPTH GAUGE HAD FALLEN OFF. THE PROCEDURE WAS SUCCESSFULLY 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 11671377 ↗
• MalfunctionFeb 9, 2021Break; Break

  IT WAS REPORTED THAT, THE DEPTH GAUGE IS BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11300213 ↗
• MalfunctionJan 15, 2021Break

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION THE EVOS SMALL 3.5MM DEPTH GAUGE LONG CAME OUT OF WASH BROKEN. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11176916 ↗
• MalfunctionJan 14, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE HAS BROKEN OFF. THIS DID NOT HAPPEN DURING SURGERY. THIS WAS DISCOVERED UPON INSPECTION IN CPD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168585 ↗
• MalfunctionJan 14, 2021Break; Break

  IT WAS REPORTED THAT THE TIP OF THE DEPTH GAUGE HAS BROKEN OFF. THIS DID NOT HAPPEN DURING SURGERY. THIS WAS DISCOVERED UPON INSPECTION IN CPD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168583 ↗
• MalfunctionNov 3, 2020Break; Break

  IT WAS REPORTED DURING THE PROCEDURE, THAT THE TIP OF THE DEPTH GAUGE WAS BROKEN OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778167 ↗
• MalfunctionJun 10, 2020Break; Break

  IT WAS REPORTED THAT BEFORE A TRAUMA SURGERY WAS NOTICED THAT THE EVOS SMALL 3.5MM DEPTH GAUGE LONG HAS A PIECE BROKEN OFF. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE TO COMPLETE THE CASE WITH NO DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10140722 ↗
• MalfunctionMar 13, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE DEPTH GAUGE BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING AN S&N BACK-UP DEVICE. THE PATIENT WAS NOT INJURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8416479 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162078. One submission often covers many models, so check the product and lot details in each record.

• Z-0265-2022 · Oct 25, 2021 · Open, Classified
  Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.