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COMPREHENSIVE® SHOULDER SYSTEM 407393Recalls & reported problems

Biomet Orthopedics, LLC · Class 1

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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00880304456808), received between Oct 10, 2019 and Mar 25, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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

Device problems

  • Fracture4

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 25, 2022Fracture; Fracture

    IT WAS REPORTED THAT THE SURGEON WAS TRYING TO REMOVE THE COMPREHENSIVE BROACH FROM THE PATIENT'S HUMERUS USING THE EXTRACTION TOOL AND WHILE USING THE SLAP HAMMER THE EXTRACTION TOOL FRACTURED. ANOTHER INSTRUMENT WAS BROUGHT INTO THE ROOM TO USE AND THAT ONE BROKE AS WELL. NO FOREIGN BODY WAS RETAIN NO REPORT OF ANY HARM TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13901264 ↗
  • MalfunctionMar 25, 2022Fracture; Fracture

    IT WAS REPORTED THAT THE SURGEON WAS TRYING TO REMOVE THE COMPREHENSIVE BROACH FROM THE PATIENT'S HUMERUS USING THE EXTRACTION TOOL AND WHILE USING THE SLAP HAMMER THE EXTRACTION TOOL FRACTURED. ANOTHER INSTRUMENT WAS BROUGHT INTO THE ROOM TO USE AND THAT ONE BROKE AS WELL. NO FOREIGN BODY WAS RETAIN NO REPORT OF ANY HARM TO THE PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13901255 ↗
  • MalfunctionNov 6, 2019Fracture; Fracture

    NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORTING.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9284484 ↗
  • MalfunctionOct 10, 2019Fracture; Fracture

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Patient problems: No Information

    MAUDE report 9175367 ↗

Other EXTRACTOR devices

All EXTRACTOR devices →

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