BIOSURE 72202746Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010648990), received between Nov 24, 2017 and May 31, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 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 9-10MM BROKE. THE BROKEN PARTS OF THE ANCHOR REMOVED FROM THE PATIENT USING 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 25342877 ↗
• MalfunctionMay 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION; AFTER THE TENDON IMPLANTATION, THE TIBIAL END WAS FIXED. AFTER CONFIRMING THAT THE TENDONS WERE NOT TWISTED OR CROSSED IN THE TIBIAL TUNNEL, THE TENDONS WERE PULLED IN PAIRS AND TIED AT 10CM AWAY FROM THE TUNNEL ENTRANCE. THE UPPER COILS OF THE BIOSURE TENSIONER WERE PULLED IN LINE WITH THE TIBIAL TUNNEL, AND THE BIOSURE DILATOR 9-10MM WAS INSERTED INTO THE MIDDLE OF THE TENDONS TO SEPARATE THEM AND SQUEEZE THEM TO THE TUNNEL WALL. CONTINUE INSERTING THE DILATOR TO THE DEPTH LIMITER ABOVE THE TIBIAL TUNNEL OPENING TO TOUCH THE CORTEX. THE GUIDE WIRE WAS INSERTED INTO THE MIDDLE CHANNEL OF THE PULLER, PLACE THE FIXED WING OF THE BIOSURE SYNC TIBIAL FIXATION ON THE BIOSURE INSERTER, AND INSERT THE FIXED WING INTO THE TIBIAL CANAL THROUGH THE GUIDE WIRE. THE FIXED WING WAS FOUND TO BE BROKEN WHEN ENTERING THE THIRD OF THE WAY, AND THE FIXED WING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING A 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 21954567 ↗
• MalfunctionFeb 21, 2024Difficult to Insert; Material Integrity Problem; Material Twisted/Bent; Difficult to Insert; Material Integrity Problem; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, A BIOSURE PK SCREW COULD NOT BE INSERTED INTO THE BIOSURE TIBIAL FIXATION DEVICE. THE ISSUE WAS NOTED WHEN THE FIXATION DEVICE WAS ALREADY IMPLANTED, THEREFORE, IT 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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753939 ↗
• InjuryAug 11, 2022Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215156 ↗
• InjuryAug 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY A BIOSURE SCREW'S "WING" BROKE WHILE IMPLANTATION. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE. THE INSERTION SITE WAS PREPARED WITH A DRILL SIZE 10MM SAME AS THE TUNNEL´S SIZE. BONE QUALITY WAS NORMAL. THE BROKEN PIECES WERE RETRIEVED WITH TWEEZERS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215155 ↗
• MalfunctionMay 14, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT WHEN OPEN THE PACKAGE OF THE BIOSURE SYNC TIBIAL FIXATION, IT WAS FOUND A FIBER. A DELAY LESS OR EQUAL THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11827993 ↗
• MalfunctionNov 24, 2017Break

  IT WAS REPORTED THAT AFTER THE BIOSURE SYNC 9-10MM TIBIAL FIXATION WAS IMPLANTED, WHEN TWISTING THE SCREW, BIOSURE SYNC BROKE IN THE BONE TUNNEL, THEN TOOK OUT THE SCREW AND BROKEN BIOSURE SYNC IN TURN, IMPLANTED THE SCREW AGAIN WITHOUT A NEW BIOSURE SYNC TO COMPLETE THE SURGERY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7057830 ↗