EXPEDIUM 279722600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034199399), received between Aug 17, 2017 and Jan 8, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCT IS WORN DUE TO USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006998 ↗
• MalfunctionSep 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THIS WAS AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2022. THE TIP OF THE TIGHTENER IN QUESTION WAS BROKEN WHEN THE SURGEON MADE THE TIGHTENING A LITTLE STRONGER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) DI FINAL TIGHTENER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15454064 ↗
• MalfunctionAug 17, 2017Break; Break

  ITEM 1: X 25 FINAL TIGHTENER 2797.12.600 IS BURRED AND NEEDS TO BE REPLACED - SURGEON REQUEST. THE SECOND X 25 FINAL TIGHTENER WAS THEN USED. NO TIME WAS LOST. ITEM 2: DI CASTLE INNIE TIGHTENER 2797.22.600 THERE ARE X 4 POINTS AT THE END OF THE INSTRUMENT AND IT WAS NOTED AT THE END OF THE OPERATION THAT X 1 TIP WAS MISSING. THE SURGEON COULD NOT SEE THE TIP IN THE OPERATING FIELD AND WAS HAPPY TO CONTINUE. NO TIME WAS LOST. NO REPORTED AE TO PATIENT. NO DELAY TO PROCEDURE. 'PRODUCT DISCARDED' HAS BEEN SELECTED FOR PRODUCT STATUS IN THIS INSTANCE AS THERE IS NO APPROPRIATE STATUS AVAILABLE TO REPRESENT THE FOLLOWING LOCAL PROCESS: INSTRUMENT WILL BE SENT TO LOCAL ENGINEERING FOR ASSESSMENT OF WEAR AND TEAR. IF 'WEAR AND TEAR' IS ASSIGNED, A COPY OF THE LOCAL ASSESSMENT WILL BE PROVIDED TO THE MANUFACTURER FOR THEIR RECORD AND CASE CLOSURE. IN THE CASE WEAR AND TEAR CANNOT BE ASSIGNED BY THE ENGINEER, THE PRODUCT WILL BE RETURNED TO THE MANUFACTURER AS A 'PRODUCT COMPLAINT' FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6801797 ↗