BIOSURE 72202273Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010622082), received between Oct 13, 2017 and Dec 29, 2023 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE BREAK IN THE FIRST CONTACT WITH THE PATIENT BONE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419464 ↗
• MalfunctionNov 23, 2023Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED THE DURING AN ARTHROSCOPY, THE BIOSURE PK SCREW WAS STUCK IN THE SHAFT. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A S+N BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18202868 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL, A BIOSURE PK SCREW BROKE DURING INSERTION; THE BROKEN PIECES WERE REMOVED FROM THE JOINT. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083665 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 (B)(6) ACL REGISTRY IMPLANT REPORT, AN UNKNOWN AMOUNT OF PATIENTS REQUIRED A REVISION SURGERY AFTER AN ACL PROCEDURE USING BIOSURE PK SCREW DEVICES. IT IS UNKNOWN HOW WERE THE EVENTS TREATED/RESOLVED. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15818288 ↗
• MalfunctionDec 24, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE BIOSURE HAD A SLIGHT DIVET IN THE HEAD, IT SEEMS TO BE A DETACHED FRAGMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACKUP DEVICE. NO PATIENT INJURIES OR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11072245 ↗
• MalfunctionDec 24, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE BIOSURE HAD A SLIGHT DIVET IN THE HEAD, IT SEEMS TO BE A DETACHED FRAGMENT BUT THE SURGEON DECIDED TO IMPLANT IT ANYWAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT INJURIES 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11072244 ↗
• MalfunctionDec 24, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE BIOSURE HAD A SLIGHT DIVET IN THE HEAD WHICH SEEMS TO BE A DETACHED FRAGMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACKUP DEVICE. NO PATIENT INJURY OR 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11072229 ↗
• MalfunctionSep 14, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, WHEN THE DOCTOR ATTEMPTED TO USE A "9X30MM BIOSURE PEEK SCREW" FOR FIXATION IN THE TIBIA, IT WAS NOTICED WHEN REMOVING THE DEVICE FROM THE PACKAGING, THAT THERE WAS A SMALL PART OF THE THREAD THAT APPEARED TO BE PEELING OFF. THEREFORE, DR. THOUGHT THIS MAY CAUSE DAMAGE TO THE INTEGRITY OF THE SCREW. IN CONSEQUENCE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING ANOTHER "9X30MM BIOSURE PEEK SCREW". NO PATIENT INJURIES OR 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 Known Impact Or Consequence To Patient

  MAUDE report 10532455 ↗
• MalfunctionMay 24, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE ITEM BROKE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8639856 ↗
• InjuryNov 17, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD AN ACL RECONSTRUCTION. PATIENT CAME BACK COMPLAINING OF PAIN AROUND THE TIBIAL FIXATION SITE. MRI SHOWS LARGE CYSTS CONTAINING AROUND 40-50ML OF A JELLY LIKE SUBSTANCE. A SECOND SURGERY WAS REQUIRED YEARS AFTER THE INITIAL ACL TO REMOVE THE SCREWS.

  Patient problems: Cyst(s); Pain

  MAUDE report 7041554 ↗
• MalfunctionOct 13, 2017Break; Component Falling; Difficult to Advance

  IT WAS REPORTED THAT ONE PATIENT WAS HAVING A STANDARD ACL RECONSTRUCTION USING HAMSTRING TENDONS SECURED WITH ENDOBUTTON (FEMUR) AND BIOSURE PK. THE ALLOGRAFT WAS SIZED AS 9MM AND A 9MM HOLE WAS DRILLED IN THE TIBIA. AFTER THE GRAFT WAS INSTITUTED A 1.2MM GUIDEWIRE WAS INSERTED AND THE CHOSEN 9 X 30MM BIOSURE PK SCREW WAS INSERTED. IT APPEARED NOT EASILY INSERTED AND HAD NO BITE IN THE TISSUE. ON REMOVAL OF THE SCREW IT WAS NOTED THAT THE TIP HAD BROKEN OFF. ANOTHER 9 X 30MM BIOSURE PK SCREW WAS CHOSEN AND IT WAS INSERTED WITHOUT ANY PROBLEMS. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6949857 ↗