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NA 86-9054Recalls & reported problems

Depuy (Ireland) · MIKHAIL COLLATERAL LIGAMENT RETRACTOR · Class 1

Adverse event reports
23
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295218111), received between Apr 16, 2024 and Nov 17, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (23 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: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 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: 2 reportsNov 2025: 20 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 reports20242025202620
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break23

Patient problems

  • No Clinical Signs, Symptoms or Conditions23

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569551 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569549 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569548 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569544 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569543 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569542 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569541 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569539 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569537 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569477 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569474 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569467 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569466 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569465 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569463 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569461 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569447 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569412 ↗
  • MalfunctionNov 17, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE IS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23569405 ↗
  • MalfunctionNov 14, 2025Break; Break

    IT WAS REPORTED THAT THE DEVICE WAS BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23555664 ↗
  • MalfunctionOct 31, 2025Break; Break

    IT WAS REPORTED THAT THE RETRACTORS WERE BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23435339 ↗
  • MalfunctionOct 31, 2025Break; Break

    IT WAS REPORTED THAT THE RETRACTORS WERE BROKEN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23435323 ↗
  • MalfunctionApr 16, 2024Break; Break

    THIS INSTRUMENT IS COMPOSED OF 1 PART. THE TIP OF THE INSTRUMENT HAS BROKEN OFF. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19121472 ↗

Other RETRACTOR devices

All RETRACTOR devices →

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