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QUADTRAC 72205610Recalls & reported problems

Smith & Nephew, Inc. · QUAD CUTTER · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556818336), received between Sep 29, 2023 and Sep 2, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 4 reportsDec 2023: 0 reportsJan 2024: 3 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 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: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break11
  • Physical Resistance/Sticking2
  • Detachment of Device or Device Component1
  • Fracture1
  • Material Deformation1
  • Material Twisted/Bent1

Patient problems

  • No Clinical Signs, Symptoms or Conditions13

Recent adverse event reports

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

  • MalfunctionSep 2, 2024Break; Break

    IT WAS REPORTED THAT, DURING A CUTTING TENDON PROCEDURE, THE QUAD CUTTER WAS BROKE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20122512 ↗
  • MalfunctionMar 19, 2024Break; Material Twisted/Bent; Physical Resistance/Sticking; Break; Material Twisted/Bent; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE QUAD CUTTER BLADE WAS STUCK IN THE DISTAL TIP. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18935604 ↗
  • MalfunctionMar 13, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE DISPOSABLE BLADE THAT WAS INSERTED INTO THE QUAD CUTTER BECAME STUCK AND COULD NOT BE REMOVED. THE DISPOSABLE BLADE WAS BENT AND DID NOT COME OUT DESPITE MULTIPLE ATTEMPTS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18897438 ↗
  • MalfunctionJan 31, 2024Break; Break

    IT WAS REPORTED THAT, AFTER AN ACL RECON, THE QUADCUTTER'S TIP FELL OFF, THE PART THAT HOLDS THE HEAD/CUTTER ON THE SHAFT WAS WEAK. AS THIS WAS NOTICED AFTER THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18614776 ↗
  • MalfunctionJan 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    IT WAS REPORTED THAT AFTER AN ACL PROCEDURE, IT WAS NOT POSSIBLE TO GET THE BLADE OUT OF THE QUAD CUTTER, THE CUTTER DETACHED FROM THE SHAFT. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18614632 ↗
  • MalfunctionJan 26, 2024Break; Break

    IT WAS REPORTED THAT THE TIP OF THE QUAD CUTTER BROKE AND WENT MISSING. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18587501 ↗
  • MalfunctionNov 28, 2023Break; Break

    IT WAS REPORTED THAT THE CUTTER MECHANISM OF THE QUAD CUTTER BROKE OFF FROM THE SHAFT WHEN THE BLADE WAS BEING REMOVED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT AND IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18222033 ↗
  • MalfunctionNov 28, 2023Break; Material Deformation; Break; Material Deformation

    IT WAS REPORTED THAT AFTER A PROCEDURE, AN ATTEMPT WAS MADE TO REMOVE THE QUAD CUTTER DISPOSABLE BLADE, BUT THE DEVICE BROKE AT THE END. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18221611 ↗
  • MalfunctionNov 23, 2023Break; Break

    IT WAS REPORTED THAT, AFTER A PROCEDURE, THE TIP OF THE QUAD CUTTER BROKE WHEN THE DISPOSABLE BLADE WAS REMOVED. AS THE EVENT HAPPENED AFTER THE PROCEDURE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18198636 ↗
  • MalfunctionNov 20, 2023Break; Break

    IT WAS REPORTED THAT THE QUAD CUTTER BROKE OFF THE END WHEN TRIED TO REMOVE THE DISPOSABLE BLADE. SINCE INCIDENT OCCURRED AFTER PROCEDURE; PATIENT WAS NO LONGER INVOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18173186 ↗
  • MalfunctionOct 4, 2023Break; Break

    IT WAS REPORTED THAT AFTER SURGERY, THE TIP OF THE QUAD CUTTER WAS BROKEN OFF FROM THE BARREL OF THE GUN. THERE WAS NO DELAY REPORTED AND A BACKUP DEVICE WAS NOT REQUIRED SINCE THE PROCEDURE WAS ALREADY FINISHED, AND THERE WAS NO PATIENT INVOLVED WHEN THE ISSUE WAS IDENTIFIED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17873705 ↗
  • MalfunctionOct 3, 2023Fracture; Fracture

    IT WAS REPORTED THAT AFTER A PROCEDURE, THE QUAD CUTTER¿S END PIECE, WHICH HOLDS THE CUTTING BLADE, SHEARED OFF FROM THE SHAFT. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17862126 ↗
  • MalfunctionSep 29, 2023Break; Break

    IT WAS REPORTED THAT THE BLADE WAS STUCK IN THE QUAD CUTTER HEAD. ONCE TOO MUCH FORCE WAS APPLIED, THE HEAD POPPED OFF THE HANDLE. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17848484 ↗

Sources and updates

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