EVOS 71174922Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556387399), received between Aug 12, 2020 and Apr 18, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

2 other recalls cover devices cleared under the same FDA submission (K132886); 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, ONE (1) DEPTH GAUGE FOR 2.0MM SCREWS BROKE. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF THIS CAUSED ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919501 ↗
• MalfunctionNov 7, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, ONE (1) DEPTH GAUGE FOR 2.0MM SCREWS BROKE OFF. THE PROCEDURE WAS RESUMED, WITHOUT DELAY, WITH 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 20630277 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED THAT DURING HANDLING ACTIVITIES ON A PLATE PROCEDURE SURGERY, THE TIP OF ONE (1) DEPTH GAUGE FOR 2.0MM SCREWS BROKE EXTERNAL TO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL 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 17547513 ↗
• MalfunctionApr 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE DEPTH GAUGE FOR 2.0MM SCREWS HAS SNAPPED AT END DURING THE CLEANING PROCESS. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14072337 ↗
• MalfunctionJan 27, 2022Break; Break

  IT WAS REPORTED THAT A DEPTH GAUGE FOR 2.0MM SCREWS BROKE IN TRANSIT. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13365432 ↗
• MalfunctionOct 15, 2021Break; Break

  IT WAS REPORTED THAT A DEPTH GAUGE FOR 2.0MM SCREWS BROKE OFF. AS THIS WAS HAPPENED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643455 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED THAT, THE DEPTH GAUGE FOR 2.0MM SCREWS BROKE. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY, IF THERE WAS PATIENT INVOLVEMENT, NOR IF THERE WAS ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431111 ↗
• MalfunctionFeb 25, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING INSPECTION, WAS NOTICED THAT THE GRADUATION HASHMARKS ON THE DEPTH GAUGE WOULD NOT DENOTE 2MM INCREMENTS, MAKING THE DEPTH DIFFICULT FOR SURGEONS TO READ. THIS IS THE OLD STYLE DEPTH GAUGE BEFORE THESE HASHMARKS WERE UPDATED TO SHOW 2MM INCREMENTS. SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE AND NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT. 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 11376933 ↗
• MalfunctionSep 30, 2020Break; Break

  IT WAS REPORTED THAT THE DEPTH GAUGE BROKE OUTSIDE OF PATIENT, S&N BACKUP DEVICE AVAILABLE. NO HARM TO PATIENT DUE THIS. 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 10610256 ↗
• MalfunctionSep 7, 2020Break; Break

  IT WAS REPORTED THAT THE GAUGE WAS FOUND BROKEN DURING SURGERY. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. AN S&N BACKUP WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10500105 ↗
• MalfunctionAug 31, 2020Break; Break

  IT WAS REPORTED THAT THE ITEM BROKE DURING SURGERY, WITH INSTRUMENTS OUTSIDE THE PATIENT. PROCEDURE WAS COMPLETED WITH A SN BACKUP DEVICE. NO SURGICAL DELAY WAS REPORTED. NO OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. 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 10474498 ↗
• MalfunctionAug 21, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE GUIDE BROKE WHILE MEASURING FOR A SCREW. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND BACKUP FROM SMITH & NEPHEW WAS AVAILABLE TO FINISH THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10437204 ↗
• MalfunctionAug 20, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  PHYSICIAN REPORTED THAT DURING AN UNKNOWN SURGICAL PROCEDURE, THE ETCH MARKS ON THE DEPTH GAUGE SEEMED TO BE LESS DARK COMPARED WITH THE NEWER ONES RECEIVED. THIS CONDITION WAS NOTED IN THE INSTRUMENTS CURRENTLY IN USE BY THE CUSTOMER AFTER REPEATED USES. THE REPORTER CONFIRMED THAT THE MARKS ARE LEGIBLE AND CORRECT AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT ANY DELAY AND THERE WAS NO PATIENT IMPACT REPORTED. PHYSICIAN ALSO MENTIONED THAT THE MARKS COULD BE MADE SO THAT THEY DIFFER IN LENGTH TO IMPROVE USABILITY OF THE DEVICE IN FUTURE DESIGNS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10432876 ↗
• MalfunctionAug 12, 2020Break; Break

  IT WAS REPORTED THAT, AFTER SURGERY, THE ITEM BROKE AND IS UNUSABLE. 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. ABSOLUTELY 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 10398411 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132886. One submission often covers many models, so check the product and lot details in each record.

• Z-0396-2018 · Dec 11, 2017 · Terminated
  smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442024, QTY: (
• Z-0397-2018 · Dec 11, 2017 · Terminated
  smith&nephew Mini-Fragment Plating System, VLP(R) Mini-Mod Small Bone Plating System, EVOS(R) Mini Plating system, 2.0MM STOUT STRAIGHT PLATE, 8 HOLE VLP(R) MIN-MOD, REF 74442030,