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EVOS 71174910Recalls & reported problems

Smith & Nephew, Inc. · 2.0MM DRILL SHORT WITH AO QUICK CONNECT · Class 1

Adverse event reports
13
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556386798), received between May 21, 2019 and Apr 6, 2026 — classified as 4 injuries, 9 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 1 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break7
  • Fracture6
  • Physical Resistance/Sticking2
  • Separation Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions8
  • Device Embedded In Tissue or Plaque2
  • No Consequences Or Impact To Patient2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 6, 2026Break

    IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, ONE (1) 2.0MM DRILL SHORT W/AO QC BROKE WHILE FINISHING THE DRILLING. THERE WAS NO FRACTURE TO THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24789475 ↗
  • MalfunctionNov 30, 2023Fracture; Fracture

    IT WAS REPORTED THAT DURING A CLAVICLE INTERNAL FIXATION, THE 2.0MM DRILL SHORT W/AO QC BROKE IN THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND COULD NOT SEPARATE. ALL PIECES WERE ACCOUNTED FOR. 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 18237271 ↗
  • MalfunctionSep 13, 2023Fracture; Fracture

    IT WAS REPORTED THAT, DURING A OSTEOSYNTHESIS OF THE TIBIA, WHEN THE DOCTOR WENT TO DRILL USING THE 2.0MM DRILL SHORT W/AO QC IT BROKE BECAUSE IT HIT THE NAIL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. THE DOCTOR REMOVED THE TIP OF THE DRILL WITH KELLY FORCEPS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17741920 ↗
  • MalfunctionAug 28, 2023Fracture; Physical Resistance/Sticking; Fracture; Physical Resistance/Sticking

    IT WAS REPORTED THAT, DURING A CLAVICLE ORIF, A 2.0MM DRILL SHORT BROKE INSIDE A 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE AND COULD NOT BE REMOVED FROM THE MENTIONED GUIDE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO PIECES FELL INTO THE PATIENT, THE DRILL BROKE OFF CLEAN. IT WAS CONFIRMED THAT THE END OF THE DRILL BIT WAS STILL STICKING OUT OF THE OTHER SIDE OF THE GUIDE AND NO OTHER PIECES WERE MISSING. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17638415 ↗
  • InjuryApr 12, 2023Fracture; Fracture

    IT WAS REPORTED THAT, DURING AN OSTEOSYNTHESIS FOR MULTIPLE FRACTURES OF THE DISTAL HUMERUS OF A CHILD, THE 2.0MM DRILL SHORT W/AO QC BROKE OFF IN ONE OF THE MANY PERFORATIONS FOR PLACING THE SCREWS. IT WAS ATTEMPTED TO REMOVE THE BROKEN PIECE FROM THE BONE BY USING THE RESPECTIVE TECHNIQUE WITH THE USE OF A VARIABLE ANGLE DRILL GUIDE, BUT IT WAS NOT POSSIBLE, SO THE SURGEON DECIDED TO LEAVE IT THERE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN S+N BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM, THE PATIENT'S HEALTH CONDITION IS STABLE.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 16727983 ↗
  • MalfunctionDec 12, 2022Fracture; Fracture

    IT WAS REPORTED THAT, DURING SURGERY, THE 2.0MM DRILL SHORT W/AO QC BECAME INCARCERATED INTO THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE. THE DRILL WAS COMPLETED STUCK AND ATTEMPTS TO REMOVE RESULTED IN THE DRILL BREAKING AT BOTH ENDS. NOTHING FELL INTO THE PATIENT. THE DRILL GUIDE WAS NEW, IT HAS NEVER BEEN USED. 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 15964459 ↗
  • InjuryOct 26, 2022Fracture; Fracture

    IT WAS REPORTED THAT, DURING AN OSTEOSYSNTESIS OF THE LEFT HUMERUS, A 2.0MM DRILL SHORT W/AO QC WAS USED WHICH BROKE IN THE PATIENT'S BONE WITHOUT BEING ABLE TO EXTRACT IT. IT IS UNKNOWN HOW SURGERY WAS COMPLETED AND IF THERE WAS A DELAY. THE PATIENT'S HEALTH WAS NOT AFFECTED.

    Patient problems: Device Embedded In Tissue or Plaque

    MAUDE report 15674476 ↗
  • MalfunctionMay 18, 2022Break; Separation Failure; Break; Separation Failure

    IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, A 2.0MM DRILL SHORT WITH AO QUICK CONNECT GOT STUCK IN THE 2.0/2.7MM DOUBLE-ENDED DRILL GUIDE, AND BROKE. NO PIECES FELL INSIDE OF PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14431858 ↗
  • MalfunctionJan 24, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

    IT WAS REPORTED THAT, DURING AN INTERNAL FIXATION SURGERY, WHEN PLACING THE 2.0MM DRILL SHORT W/AO QC IN THE 2.0 GUIDE, THE DRILL GOT STUCK IN THE GUIDE AND WHEN TRYING TO TAKE IT OUT, THE DRILL BROKE. INCIDENT OCCURRED OUTSIDE THE PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13339510 ↗
  • InjuryJan 8, 2021Break; Break

    IT WAS REPORTED THAT DURING A REVISION SURGERY THE 2.0MM DRILL SHORT W/AO QC BIT BROKE WHILE BEING USED TO DRILL A PILOT HOLE FOR A SCREW. THE INSTRUMENT BROKE INSIDE PATIENT. S&N BACKUP DEVICE AVAILABLE. NO SURGICAL DELAY OR PATIENT HARM REPORTED DUE THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11142853 ↗
  • InjuryJul 17, 2020Break; Break

    IT WAS REPORTED THAT DURING A REVISION SURGERY THE 2.0MM DRILL SHORT W/AO QC BROKE WHILE BEING USED INSIDE THE PATIENT TO DRILL A PILOT HOLE FOR A SCREW, ALL PIECES WERE RETRIEVED. REASON FOR REVISION: PATIENT DIDN'T HEAL AFTER HAVING COMPETITIVE DEVICES PUT IN. NO DELAY. PROCEDURE WAS FINISHED USING A S&N BACK UP DEVICE. 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 10292072 ↗
  • MalfunctionDec 6, 2019Break; Break

    IT WAS REPORTED THAT DURING SURGERY, WHILE THE DOCTOR WAS DRILLING WITH THE 2.0 DRILL, THE DRILL GUIDE SNAPPED OFF AND WAS ON THE DRILL BIT (NO PARTS FELL INTO THE PATIENT). THIS DID NOT ADD ANY SUBSTANTIAL TIME TO THE CASE BECAUSE AN S&N BACK UP WAS AVAILABLE. THERE WAS NO HARM TO THE PATIENT OR STAFF.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9429276 ↗
  • MalfunctionMay 21, 2019Break; Break

    IT WAS REPORTED THAT 2.0 DRILL BIT BROKE INSIDE THE TISSUE PROTECTOR DURING SURGERY. NO DELAY REPORTED. UNKNOWN IF SNN BACKUP WAS USED OR REQUIRED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8628569 ↗

Other BIT, DRILL devices

All BIT, DRILL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.