BIOSURE 72202752Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010649010), received between Oct 10, 2018 and Aug 13, 2021 — classified as 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2021Break; Break

  IT WAS REPORTED THAT DURING AN KNEE PROCEDURE, WHEN INSERTING THE FIXATION DEVICE WITH THE BIOSURE SYNC INSERTER, THE INSERTER LOCKING MECHANISM ON THE INSTRUMENT BROKE. NO BROKEN PIECES FELT INSIDE THE PATIENT. THE SURGEON HAD TO ADJUST HIS TECHNIQUE BECAUSE OF THE FAULTY INSTRUMENT AND USE AN ALTERNATE BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321372 ↗
• MalfunctionOct 10, 2018Break

  IT WAS REPORTED THAT THE BLACK PLASTIC SLEEVE BROKE OFF DURING IMPLANT INSERTION. CORRECT SURGICAL TECHNIQUE USED. PROPER SIZED DILATOR WAS USED PRIOR TO SYNC IMPLANT INSERTION. PLASTIC CHIP WAS RETRIEVED AND DISCARDED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7952213 ↗