EVOS 71175069Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00885556635872), received between Nov 1, 2019 and Mar 7, 2026 — classified as 1 injury, 27 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2026Fracture

  IT WAS REPORTED THAT, DURING AN ORIF SURGERY, THE TIP OF ONE (1) EVOS SMALL 3.5MM DEPTH GAUGE SHORT BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541645 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ORIF FOREARM SURGERY, THE EVOS SMALL 3.5MM DEPTH GAUGE SHORT TIP BROKE OFF DURING NORMAL USE. NO PIECES FELL INSIDE PATIENT. 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 23822321 ↗
• MalfunctionApr 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, AN EVOS SMALL 3.5MM DEPTH GAUGE SHORT 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 21915665 ↗
• MalfunctionJul 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING ORIF SURGERY, THE TIP OF ONE (1) EVOS SMALL 3.5MM DEPTH GAUGE SHORT BROKE AND WAS UNUSABLE. THE PROCEDURE WAS RESUMED USING A S+N BACKUP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19844614 ↗
• MalfunctionJul 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING ORIF SURGERY, THE HOOK TIP OF ONE (1) EVOS SMALL 3.5MM DEPTH GAUGE SHORT BROKE OFF OR WORE OFF. THE DEVICE CANNOT BE USED TO HOOK ON THE FAR CORTEX BECAUSE OF THE AFOREMENTIONED PROBLEM. THE TIP WAS NOT FOUND IN THE WOUND UNDER X-RAY. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643988 ↗
• MalfunctionJan 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATION SURGERY, WHILE PLATING, THE TIP OF ONE (1) EVOS SMALL 3.5MM DEPTH GAUGE SHORT SNAPPED OFF. 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 18536472 ↗
• MalfunctionJun 13, 2023Fracture; Fracture

  IT WAS REPORTED, THAT THE TIP OF ONE (1) EVOS SMALL 3.5MM DEPTH GAUGE SHORT BROKE OFF DURING THE PROCEDURE. WHEN TRYING TO GET A MEASUREMENT FOR SCREW PLACEMENT. THE SURGERY STAFF DID NOT NOTICE THE PIECE HAD BROKEN OFF THE INSTRUMENT, UNTIL AFTER THE CASE WAS COMPLETE. THE SURGEON WAS NOT CONCERNED ABOUT THE MISSING PIECE. NO X-RAYS ARE AVAILABLE AT THIS TIME. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17122020 ↗
• MalfunctionMar 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A PLATE PROCEDURE, THE HOOK AT THE END OF A EVOS SMALL 3.5MM DEPTH GAUGE SHORT BROKE OFF AND A RDCE FRCPS W/ PTS {} BRD WAS NOTICED TO BE BENT. HOWEVER, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16583933 ↗
• MalfunctionAug 17, 2022Fracture; Fracture

  IT WAS REPORTED THAT, UPON INSPECTION FOR A TRAUMA CASE, THE HOOK AT THE TIP OF A EVOS SMALL 3.5MM DEPTH GAUGE SHORT WAS BROKEN OFF. NO SURGICAL DELAY OCCURRED AS A CONSEQUENCE OF THIS ISSUE AND THE PROCEDURE WAS ABLE TO BE CONCLUDED WITH A BACK UP DEVICE. NO PATIENT WAS YET INVOLVED AT THE MOMENT THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245526 ↗
• MalfunctionJul 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT BEFORE SURGERY, THE TIP OF THE EVOS SMALL 3.5MM DEPTH GAUGE SHORT WAS NOTICED TO BE BROKEN OFF. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021553 ↗
• MalfunctionJun 29, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT DURING AN INTERNAL FIXATIONS SURGERY, THE HOOK TIP OF AN EVOS SMALL 3.5MM DEPTH GAUGE SHORT WAS MISSING. SURGERY WAS FINISHED AFTER A NON-SIGNIFICANT DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14859730 ↗
• MalfunctionApr 12, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF AN EVOS SMALL 3.5MM DEPTH GAUGE SHORT IS BROKEN. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14079946 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT THE EVOS SMALL 3.5MM DEPTH GAUGE SHORT WAS BROKEN IN THE WASHER. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087802 ↗
• MalfunctionNov 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING TRAUMA SURGERY, THE EVOS SMALL 3.5MM DEPTH GAUGE SHORT BROKE 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 12875258 ↗
• InjuryNov 18, 2021Imprecision; Imprecision

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AN EVOS SMALL 3.5MM DEPTH GAUGE SHORT WAS NOTICED TO HAVE THE ORANGE DOT MISSING AND IT WAS INCORRECTLY ASSEMBLED WITH A 2.7MM INSERT. THE SCREW LENGTH INCORRECTLY MEASURED WAS INSERTED INTO PATIENT. SURGERY WAS COMPLETED, AFTER A DELAY OF 30 MINUTES OR LESS, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12836546 ↗
• MalfunctionSep 2, 2021Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION FOR AN UNKNOWN SURGERY, THE TIP OF A EVOS SMALL 3.5MM DEPTH GAUGE SHORT BROKE OFF. NO SURGICAL DELAY OCCURRED AS A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE TO PERFORM THE PROCEDURE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418398 ↗
• MalfunctionMar 14, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT, DURING ORIF ANKLE SURGERY IT WAS NOTICED THAT THE EVOS SMALL 3.5MM DEPTH GAUGE SHORT WAS MEASURING WRONG. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478819 ↗
• MalfunctionMar 3, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING SURGERY, THE EVOS SMALL 3.5MM DEPTH GAUGE SHORT DID MEASURE INCORRECTLY. THE PROCEDURE CONTINUED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITHOUT SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407487 ↗
• MalfunctionFeb 14, 2021Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT DURING INSPECTION THE TIP OF THE EVOS SMALL 3.5MM DEPTH GAUGE SHORT WAS SEEN TO BE MISSING. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326124 ↗
• MalfunctionFeb 5, 2021Break; Break

  IT WAS REPORTED THAT, THE TIP OF THE EVOS SMALL 3.5MM DEPTH GAUGE SHORT BROKE OFF. NO CASE REPORTED; 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 11284648 ↗
• MalfunctionDec 7, 2020Break; Break

  IT WAS REPORTED THAT DURING SET UP/ INSPECTION THE TIP OF THE EVOS SMALL 3.5MM DEPTH GAUGE SHORT WAS FOUND TO BE BROKEN. NO PIECES FELL INTO PATIENT. ISSUE WAS NOTICED BEFORE THE CASE SO TIP PROBABLY BROKE OFF DURING STERILE PROCESSING. THERE WAS NO DELAY. A S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10957040 ↗
• MalfunctionOct 22, 2020Break; Break

  IT WAS REPORTED THAT THE TIP OF THE EVOS SMALL 3.5 MM DEPTH GAUGE SHORT IS BROKEN. IT IS UNKNOWN WHEN THIS MALFUNCTION OCCURRED AND IF THERE WAS ANY PATIENT INVOLVEMENT. NO INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10720474 ↗
• MalfunctionSep 20, 2020Break; Break

  IT WAS REPORTED THAT THE HOOK ON DEPTH GAUGE BROKE OFF. IT IS UNKNOWN WHERE THE EVENT OCCURS.

  Patient problems: No Information

  MAUDE report 10558293 ↗
• MalfunctionSep 15, 2020Break; Break

  IT WAS REPORTED THAT THE HOOK OF THE DEPTH GAUGE BROKE OFF. UNKNOWN IF S&N BACKUP AVAILABLE, UNKNOWN PROCEDURE. UNKNOWN IF PATIENT INVOLVED.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10538771 ↗
• MalfunctionAug 6, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. USED AN IDENTICAL BACKUP DEVICE TO COMPLETE SURGERY. SURGERY TIME WAS NOT EXTENDED MORE THAN 30 MIN. THE SURGEON DOES NOT FAULT THE DEVICE. THE PATIENT OR SURGICAL PROCEDURE WAS NOT AFFECTED IN ANY WAY DUE TO THE PROBLEM. NO BROKEN PIECES FELL INTO THE PATIENT¿S WOUND AT ALL AND THE DEVICE DID NOT BREAK OVER THE INCISION OR WOUND.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10375887 ↗

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.