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EXPEDIUM 279703150PRecalls & reported problems

Medos International Sàrl · POWERED INSTRUMENTS EXPEDIUM SYSTEM T-HANDLE, RATCHETING, QUICK COUPLING 5.5 · Class 1

All models of EXPEDIUM (291)

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

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034476605), received between Oct 2, 2023 and Nov 18, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (3 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: 2 reportsDec 2023: 0 reportsJan 2024: 1 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: 1 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 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Contamination /Decontamination Problem3
  • Break1
  • Device-Device Incompatibility1
  • Mechanical Problem1

Patient problems

  • Insufficient Information3
  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 18, 2025Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

    IT WAS REPORTED THAT THE SCREW DRIVERS APPEAR TO BE WEARING AT THE DISTAL TIP AND NOT ENGAGING WITH SCREW HEAD FULLY. BUTTONS ON THE SLEEVES ARE BECOMING WORN AS WELL AND DRIVER T HANDLES ARE SQUEAKING MORE THAN USUAL AND DIFFICULT TO CONNECT TO SHAFT. ENTIRE DRIVER TOOL NEEDS REPLACING. THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23586988 ↗
  • MalfunctionJan 11, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

    IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE UNFIT FOR SURGERY DURING STERILE PROCESSING OF INCOMING FIELD INSPECTION. A BORESCOPE WAS RUN DOWN THE CANNULATED INSTRUMENTS AND FOUND THAT THEY FELL OUTSIDE OF THE GUIDELINES FOR USE IN SURGERY. THERE WAS NO REPORTED PATIENT INTERACTION, HOWEVER A SCHEDULED CASE HAD TO BE CANCELLED AS THE PROPER TOOLING WAS UNAVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE POWERED INSTRUMENTS EXPEDIUM SYSTEM T-HANDLE, RATCHETING, QUICK COUPLING 5.5. THIS IS REPORT 9 OF 9 FOR (B)(4). THIS COMPLAINT IS RELATED TO (B)(4) AND (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 18493158 ↗
  • MalfunctionNov 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

    IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE UNFIT FOR SURGERY DURING STERILE PROCESSING OF INCOMING FIELD INSPECTION. THERE WAS NO REPORTED PATIENT INTERACTION, HOWEVER A SCHEDULED CASE HAD TO BE CANCELLED AS THE PROPER TOOLING WAS UNAVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A POWERED INSTRUMENTS EXPEDIUM SYSTEM T-HANDLE, RATCHETING, QUICK COUPLING 5.5. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 18102530 ↗
  • MalfunctionNov 9, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

    IT WAS REPORTED THAT ON (B)(6) 2023, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE UNFIT FOR SURGERY DURING STERILE PROCESSING OF INCOMING FIELD INSPECTION. THERE WAS NO REPORTED PATIENT INTERACTION, HOWEVER A SCHEDULED CASE HAD TO BE CANCELLED AS THE PROPER TOOLING WAS UNAVAILABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A POWERED INSTRUMENTS EXPEDIUM SYSTEM T-HANDLE, RATCHETING, QUICK COUPLING 5.5. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Patient problems: Insufficient Information

    MAUDE report 18102523 ↗
  • MalfunctionOct 2, 2023Break; Break

    DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2023, THE HANDLE IN QUESTION BROKE DURING USE. NO FRAGMENTS WERE GENERATED, THERE WAS NO REPORTED ADVERSE PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE IN REPORT. THIS REPORT IS FOR A POWERED INSTRUMENTS EXPEDIUM SYSTEM T-HANDLE, RATCHETING, QUICK COUPLING 5.5. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17852788 ↗

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Sources and updates

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