BIOSURE 72201888Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 03596010615442), received between Oct 23, 2018 and Jul 10, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE TIP OF THE BIOSURE DRIVER (CASE (B)(4)) HAS BECOME FLARED OUT DUE TO CONTINUED USE. THIS CAUSED THREE BIOSURE REGENESORB SCREWS TO BREAK DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED USING FORCEPS, HOMEOSTAT AND SUCTION. THE SURGERY WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473620 ↗
• MalfunctionAug 3, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE SCREWDRIVER TIP BROKE WHEN IT WAS BEING PLACED. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE THROUGH THE SAME BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19901872 ↗
• MalfunctionJan 17, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, WHEN THE SURGEON WAS PUTTING AN INTERFERENCE SCREW IN THE TIBIA, THE BIOSURE RATCHET DRIVER BROKE TOWARDS THE BOTTOM WHEN THE SIZE CHANGES. THE DEVICE BROKE OUTSIDE THE PATIENT. THE SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16184789 ↗
• InjurySep 8, 2022Break; Break

  IT WAS REPORTED THAT AFTER A KNEE PROCEDURE, IT WAS NOTED THAT THE BIOSURE RATCHET DRIVER WAS FRACTURED, POTENTIALLY LEAVING A SMALL AMOUNT OF METAL IN-SITE. X-RAYS WERE REVIEWED AND NO FOREIGN BODY WAS FOUND. THE PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15383843 ↗
• MalfunctionJan 10, 2022Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE. IT WAS NOTICED THAT THE BIOSURE RATCHET DRIVER HAD A BROKEN MOUTH WHICH MADE HARD TO FITTING THE SCREW. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13203939 ↗
• MalfunctionDec 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY USING A BIOSURE RATCHET DRIVER, IT WAS NOTICED THAT THE PRODUCT KEY WAS BROKEN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120340 ↗
• InjuryAug 19, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING LCP, LCA AND LCM ARTHROSCOPY PROCEDURE, THE BIOSURE RATCHET DRIVER BROKE IN THE DOCTOR'S HANDS. THE INSTRUMENT WAS INSIDE THE PATIENT. NO DELAY AND THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10428786 ↗
• MalfunctionOct 23, 2018Flare or Flash

  IT WAS REPORTED THAT THE TIP OF THE SCREW DRIVER FLARE UP DUE TO IT WAS NECESSARY TO PUT TOO MUCH TORQUE ON THE SCREW. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7995805 ↗