BIOSURE 72202745Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 03596010648983), received between Jun 4, 2018 and May 31, 2026 — classified as 8 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BIOSURE SYNC 7-8MM BROKE. THE BROKEN PARTS OF THE ANCHOR REMOVED FROM THE PATIENT BY SUCTION AND TWEEZERS. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN S+N EQUIVALENT BACK UP PRODUCT ON THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25342976 ↗
• MalfunctionMar 17, 2026Break

  IT WAS REPORTED THAT, DURING A CL PROCEDURE, A BIOSURE SYNC 7-8MM TIBIAL FIXATION WAS FRACTURED. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION AND ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617120 ↗
• MalfunctionJul 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL REPAIR PROCEDURE, THE 7-8MM BIOSURE FIXATION DEVICE WAS BROKEN WHEN THE PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE OF 9-10 MM. THE TIBIAL TUNNEL WAS INCREASED IN DIAMETER DUE TO THE USE OF THE BACKUP 9-10 MM. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 22412629 ↗
• MalfunctionJun 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE SYNC 7-8MM TIBIAL FIXATION BROKE WHILE BEING IMPLANTED. THE DEVICE WAS REMOVED USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK-UP DEVICE ON THE ORIGINALLY DRILLED BONE HOLE, AND NO VOID WAS LEFT IN THE PATIENT. THE PATIENT'S HEALTH CONDITION IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121512 ↗
• MalfunctionApr 10, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN MENISCUS REPAIR SURGERY, THE BIOSURE SCREW DEFORMED AND BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. ALL THE PIECES WERE REMOVED FORM THE PATIENT USING TWEEZERS. THE BACK UP WAS USED IN AN ADDITIONAL DRILLED HOLE AND THERE WAS A VOID LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21811091 ↗
• MalfunctionNov 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE SYNC 7-8MM TIBIAL FIXATION BROKE. THE BROKEN PARTS WERE RETRIEVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20758390 ↗
• MalfunctionJun 27, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE SCREW COULD NOT BE INSERTED INTO THE BIOSURE SYNC TIBIAL FIXATION DEVICE, DID NOT ENTER THE BONE TUNNEL. THE BIOSURE SYNC TIBIAL FIXATION WAS REMOVED FROM THE PATIENT WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19624653 ↗
• MalfunctionMay 3, 2024Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW COULD NOT BE INSERTED INTO THE BIOSURE TIBIAL FIXATION DEVICES. AFTER SEVERAL FAILED IN THE PATIENT'S BODY, IT WAS TRIED AGAIN OUTSIDE THE PATIENT'S BODY AND IT BROKE. THE TUNNEL WAS UNOBSTRUCTED AND THE TENDON FASCICLES WERE CLEAR BEFORE IMPLANTATION. FINALLY, ONLY BIOSURE SCREWS WERE USED TO COMPLETE THE SURGERY, WITH A SURGICAL DELAY OF 20 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237744 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, THE BIOSURE TIBIAL FIXATION BROKE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY OF 30 MINUTES, AND USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE AND NO VOID LEFT IN THE PATIENT, AND THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR . NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021352 ↗
• MalfunctionFeb 23, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, A BIOSURE PK SCREW CANNOT BE INSERTED INTO THE BIOSURE TIBIAL FIXATION DEVICE. THE ISSUE WAS NOTED WHEN THE FIXATION DEVICES WERE ALREADY IMPLANTED, THEREFORE, THEY HAD TO BE FORCIBLY REMOVED. SURGERY WAS COMPLETED WITH A BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, WHICH WAS PREPARED WITH A 9.25MM SCREW. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768116 ↗
• MalfunctionFeb 2, 2024Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE WAS UNABLE TO IMPLANT, IT DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. PER THE PRELIMINARY RESULTS OF THE INVESTIGATION, THE VISUAL INSPECTION REVEALED THE DEVICE WAS RETURNED WITH ONE WING FRACTURED AWAY FROM THE HUB. THE WINGS ARE ALL DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631704 ↗
• MalfunctionAug 7, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE WING FROM THE BIOSURE TIBIAL FIXATION DEVICE BROKE IN THE JOINT CAVITY. ALL BROKEN PIECES WERE REMOVED BY TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE STATUS OF THE PATIENT IS HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17471750 ↗
• MalfunctionMay 12, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE TIBIAL FIXATION DEVICE BROKE WHILE IMPLANTATION. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, HOWEVER, IT IS UNKNOWN IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924906 ↗
• InjuryDec 14, 2022Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION, THE BIOSURE TIBIAL FIXATION BROKE INTO PIECES WHILE IMPLANTATION. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982991 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON REGISTRY REVIEW 2021 NEW ZEALAND ACL REGISTRY IMPLANT REPORT, AN UNKNOWN AMOUNT OF PATIENTS REQUIRED A REVISION SURGERY AFTER AN ACL PROCEDURE USING BIOSURE SYNC TIBIAL FIXATION 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 15841053 ↗
• InjuryAug 15, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY A BIOSURE "WING" BROKE WHILE IMPLANTATION. SURGERY WAS FINISHED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE USED IN THE ORIGINALLY DRILLED BONE AND NO VOIDS WERE LEFT IN THE PATIENT. INSERTION SITE WAS PREPARED WITH A DRILL SIZE 8MM SAME AS THE TUNNEL´S SIZE. BONE QUALITY WAS NORMAL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15223122 ↗
• InjuryAug 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL A BIOSURE "WING" BROKE WHILE IMPLANTATION. SURGERY WAS FINISHED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE, THE BONE QUALITY WAS NORMAL, NO VOIDS WERE LEFT IN THE PATIENT. THE INSTRUMENT USED TO PREPARE THE INSERTION SITE WAS A DRILL OF 8MM, SAME AS THE TUNNEL SIZE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215149 ↗
• InjuryAug 8, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE OF AN ARTHROSCOPY RECONSTRUCTION SURGERY, THE BIOSURE IMPLANTATION WAS FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188465 ↗
• MalfunctionMay 17, 2022Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, ONCE OPENED THE CARTON, FOUND THE BIOSURE WAS BROKE, IT COULD NOT BE USE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14415250 ↗
• InjuryDec 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE USING A 7-8MM BIOSURE , THE IMPLANT BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS FINISHED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12978973 ↗
• InjuryDec 10, 2021Crack; Crack

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE IMPLANTATION WAS FRACTURED. ALL PIECES WERE RETRIEVED FROM THE PATIENT BY TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. THE TUNNEL´S SIZE WAS 8MM. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975854 ↗
• MalfunctionMay 6, 2021Break; Break

  IT WAS REPORTED THAT DURING ACL SURGERY, WHEN THE PACKAGE WAS OPENED, THE BIOSURE WAS FOUND FRACTURED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO DELAY AND NO PATIENT INJURY 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 11782678 ↗
• InjuryFeb 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING ACL RECONSTRUCTION SURGERY, THE BIOSURE SYNC 7-8MM TIBIAL FIXATION WAS FRACTURED UPON INSERTION, ALL THE BROKEN PIECES WERE RETRIEVED. THE MALFUNCTION WAS SOLVED WITH NO SIGNIFICANT DELAYS OR PATIENT HARM USING A BACK UP DEVICE. 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 11262879 ↗
• MalfunctionAug 18, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING ACL RECONSTRUCTION SURGERY, WHEN OPENING THE PACKAGE, THE BIOSURE WAS FOUND FRACTURED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A S&N BACK-UP 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 Known Impact Or Consequence To Patient

  MAUDE report 10423627 ↗
• MalfunctionJan 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY THE DEVICE WAS FOUND FRACTURED AND IT WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP 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 Known Impact Or Consequence To Patient

  MAUDE report 9572199 ↗