EVOS 71175021Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00885556635759), received between Feb 5, 2019 and May 30, 2025 — classified as 9 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Fracture” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERNAL FIXATION SURGERY, ONE (1) EVOS SMALL 2.0MM DRILL W/AO QC SHORT BROKE OFF INSIDE OF ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE. NOTHING LEFT INSIDE OF PATIENT. 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 22115381 ↗
• MalfunctionMar 6, 2025Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT DURING AN OLECRANON ORIF PROCEDURE, AN EVOS SMALL 2.0MM DRILL W/AO QC SHORT COLD WELDED AND BROKE OFF IN THE DRILL GUIDE DURING USE. NO PIECES FELL INTO THE PATIENT. THERE WAS NO 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 21543038 ↗
• MalfunctionFeb 24, 2025Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT, DURING AN ORIF ANKLE PROCEDURE, AN (1) EVOS SMALL 2.0MM DRILL W/AO QC SHORT WAS GETTING STUCK AND BREAKING IN A (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447837 ↗
• MalfunctionFeb 24, 2025Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT, DURING AN ORIF ANKLE PROCEDURE, AN (1) EVOS SMALL 2.0MM DRILL W/AO QC SHORT WAS GETTING STUCK AND BREAKING IN A (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447828 ↗
• MalfunctionFeb 12, 2025Break; Separation Problem; Break; Separation Problem

  IT WAS REPORTED THAT, DURING AN ORIF ANKLE PROCEDURE, TWO (2) EVOS SMALL 2.0MM DRILL W/AO QC SHORT WERE GETTING STUCK AND BREAKING IN A (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT 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 21367922 ↗
• MalfunctionOct 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING INTERNAL FIXATION SURGERY (FOREARM FRACTURE), ONE (1) EVOS SMALL 2.0MM DRILL W/AO QC SHORT BROKE OFF IN ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND COULD NOT BE REMOVED FROM THE GUIDE. IT COULD NOT BE PUT THROUGH WASH IN THAT STATE, GIVEN THE SHARP POINT STICKING OUT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT 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 20368685 ↗
• InjuryJul 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AN EVOS SMALL 2.5MM DRILL W/AO QC SHORT BROKE WHILE DRILLING AN THE TIP OF THE DRILL WAS LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT IS STILL IN RECOVERY PHASE IN HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 19767963 ↗
• MalfunctionApr 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AN EVOS SMALL 2.0MM DRILL W/AO QC SHORT WAS BROKEN, IN THIS INCIDENCE IT WAS NOT FELT THAT THE DRILL BIT WAS FAULTY, MORE A CASE OF OPERATIVE DIFFICULTY AND IT "CROSSING" A K-WIRE AT POINT OF INSERTION, CAUSING IT TO BREAK. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT 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 19022567 ↗
• MalfunctionOct 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION, ONE EVOS SMALL 2.0MM DRILL W/AO QC SHORT BROKE OFF AND SNAPPED INSIDE OF ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE. NOTHING WAS LEFT INSIDE OF PATIENT ANATOMY. 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 17997456 ↗
• InjurySep 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY OF A TIBIAL FRACTURE, THE TIP OF AN EVOS SMALL 2.0MM DRILL W/AO QC SHORT BROKE DUE TO EXCESSIVE FORCE. THE TIP OF WAS NOT REMOVED AND REMAINED INSIDE THE PATIENT. IT WAS IMPOSSIBLE TO REMOVE AND THE DOCTOR CHOSE TO LEAVE IT THERE THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17741103 ↗
• InjurySep 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY OF A TIBIAL FRACTURE, THE TIP OF AN EVOS SMALL 2.0MM DRILL W/AO QC SHORT BROKE DUE TO EXCESSIVE FORCE. THE TIP OF WAS NOT REMOVED AND REMAINED INSIDE THE PATIENT. IT WAS IMPOSSIBLE TO REMOVE AND THE DOCTOR CHOSE TO LEAVE IT THERE THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER ISSUES WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17741102 ↗
• InjuryJul 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION SURGERY OF THE TIBIA AND PERONE, IN ORDER TO REDUCE THE FRACTURE, THE SPECIALIST NEEDED TO PLACE TWO SCREWS FROM CORTICAL TO CORTICAL. WHEN PERFORMING THE PASSAGE WITH THE EVOS SMALL 2.0MM DRILL W/AO QC SHORT AND LATER WHEN REMOVING IT FROM THE BONE IT WAS EVIDENCED THAT THE DRILL BIT CAME OUT INCOMPLETE. LATER X-RAY SHOWED THAT THE TIP OF THE DRILL WAS STILL INSIDE THE BONE, AND IT WAS IMPOSSIBLE TO REMOVE. THERE WAS A NON-SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17367975 ↗
• MalfunctionMay 29, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A FOREARM OSTEOSYNTHESIS A EVOS SMALL 2.0MM DRILL W/AO QC SHORT BROKE DURING DRILLING INSIDE THE PATIENT'S BONE, BUT THE BROKEN DRILL TIP WAS TRAPPED INSIDE THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE, FOR THIS REASON IT WAS NOT INSIDE THE PATIENT, IT WAS REMOVED. 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 17017218 ↗
• MalfunctionMay 23, 2023Fracture; Separation Failure; Fracture; Separation Failure

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A 2.0 SINGLE USE DRILL SNAPPED AND GOT STUCK INSIDE A 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE. 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 16986982 ↗
• MalfunctionMar 27, 2023Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, WHEN THE SURGEON WAS USING THE DRILL, THE EVOS SMALL 2.0MM DRILL W/AO QC SHORT BENT IT AND WHEN TRYING TO GET IT INTO PLACE, IT FRACTURED. EVERYTHING WAS OUT OF THE PATIENT. NO DAMAGE CAUSED, PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620896 ↗
• MalfunctionMar 27, 2023Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT DURING TRAUMA SURGERY, WHEN THE SURGEON WAS USING THE DRILL, THE EVOS SMALL 2.0MM DRILL W/AO QC SHORT BENT IT AND WHEN TRYING TO GET IT INTO PLACE, IT FRACTURED. EVERYTHING WAS OUT OF THE PATIENT. NO DAMAGE CAUSED, PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16620866 ↗
• MalfunctionMar 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING SURGERY IT WAS NOTICED THAT, ONE (1) 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE WAS DISTORTED AND DRILL BIT BROKE OFF INSIDE. 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 16558142 ↗
• InjuryMay 26, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SURGERY, A EVOS SMALL 2.0MM DRILL W/AO QC SHORT BIT BROKE INSIDE PATIENT WHILE DRILLING. PIECE WAS UNABLE TO BE REMOVE FROM PATIENT. THE PROCEDURE WAS COMPLETED, WITH A DELAY LESS THAN 30 MIN, USING A S+N BACK UP DEVICE. THE PATIENT HAS A FOREIGN BODY INSIDE. THE PATIENT'S CONDITION IS STABLE AND NO INTERVENTION HAS BEEN PLANNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14519730 ↗
• InjuryApr 28, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY AN EVOS SMALL 2.0MM DRILL W/AO QC SHORT BROKE. THE DRILL BROKE INSIDE THE PATIENT. THE PATIENT HAD A FOREIGN BODY INSIDE CAUSED BY THE BROKEN DRILL BIT. SURGERY WAS FINISHED, AFTER A DELAY OF 30 MINUTES OR LESS, WITH A SN BACK-UP DEVICE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 14232917 ↗
• MalfunctionApr 28, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AN EVOS SMALL 2.0MM DRILL W/AO QC SHORT BROKE OFF IN A 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND COULD NOT BE SEPARATED. SURGERY WAS CONTINUED, AFTER A DELAY OF 30 MINUTES OR FEWER, WITH A S+N BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14232506 ↗
• MalfunctionMar 2, 2022Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, AN EVOS SMALL 2.0MM DRILL W/AO QC SHORT GOT STUCK IN THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE WHILE DRILLING, AND THE BIT OF THE EVOS SMALL 2.0MM DRILL W/AO QC SHORT EVENTUALLY SNAPPED WHEN TRYING TO REMOVE FROM 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE. NO PIECES FELL INSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A COMPETITOR'S BACK-UP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656057 ↗
• InjuryMar 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, TWO (2) EVOS SMALL 2.0MM DRILL W/AO QC SHORT BROKE DURING SURGERY. BOTH DRILLS BROKE INSIDE PATIENT, THE PIECES OF THE FIRST ONE WERE REMOVED FROM PATIENT, HOWEVER, THE PIECES FROM THE SECOND ONE WERE NOT REMOVED. PATIENT HAD A FOREIGN BODY INSIDE CAUSED BY THE BROKEN DRILLBIT. SURGERY WAS FINISHED, AFTER A DELAY OF 30 MINUTES OR LESS, WITH A SN BACK-UP DEVICE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 13637680 ↗
• MalfunctionMar 14, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A 2.0MM DRILL W/AO QC SHORT WAS BENT AND THAT IT CAME OUT FROM AN UNDAMAGED S&N BOX. NO FURTHER INFORMATION WAS GIVEN. IT IS UNKNOWN WHEN IT HAPPENED, IF THERE WAS PATIENT INVOLVEMENT, COMPLICATIONS OR HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478841 ↗
• MalfunctionSep 15, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE DRILL GOT STUCK IN THE 2.0MM DRILL GUIDE. IT IS UNKNOWN WHEN THE EVENT OCCURS, HOW WAS THE SURGERY FINISH, IF THERE WAS A BACKUP FROM SMITH AND NEPHEW AVAILABLE TO COMPLETE THE PROCEDURE AND IF THERE WAS ANY PATIENT INVOLVED IN THE CASE. 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 10538845 ↗
• MalfunctionSep 15, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE DRILL GOT STUCK IN THE 2.0MM DRILL GUIDE. IT IS UNKNOWN WHEN THE EVENT OCCURS, HOW WAS THE SURGERY FINISH, IF THERE WAS A BACKUP FROM SMITH AND NEPHEW AVAILABLE TO COMPLETE THE PROCEDURE AND IF THERE WAS ANY PATIENT INVOLVED IN THE CASE. 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 10538832 ↗