BIOSURE 72204408Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00885554036848), received between Apr 6, 2018 and May 31, 2026 — classified as 10 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (24 reports).

1 other recall cover devices cleared under the same FDA submission (K142948); they may or may not involve this specific model.

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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL ARTHROSCOPY, UPON INSERTION THE BIOSURE SCREW BROKE IN THE TIBIAL CANAL. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING KELLY FORCEPS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE IN THE ORIGINAL BONE HOLE. PATIENT WAS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25344217 ↗
• MalfunctionFeb 21, 2026Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, A 9 MM HAMSTRING GRAFT WAS PREPARED, AND A 9 MM TIBIA ENDOSCOPY DRILL BIT WAS USED FOR THE TIBIA TUNNEL. WHILE INSERTING ONE (1) REGENESORB BIOSOURCE SCREW INTO THE TIBIA TUNNEL, IT GOT BROKEN AND PARTS OF THE SCREW WERE REMOVED FROM THE BONE. WHILE REMOVING THE PARTS, THE SCREW WAS CRUSHED INTO SMALL PIECES. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410380 ↗
• MalfunctionFeb 20, 2026Fracture

  IT WAS REPORTED THAT DURING AN ACL SURGERY, A 9 MM HAMSTRING GRAFT WAS PREPARED, AND A 9 MM TIBIA ENDOSCOPY DRILL BIT WAS USED FOR THE TIBIA TUNNEL. WHILE INSERTING ONE (1) REGENESORB BIOSOURCE SCREW INTO THE TIBIA TUNNEL, IT GOT BROKEN AND PARTS OF THE SCREW WERE REMOVED FROM THE BONE. WHILE REMOVING THE PARTS, THE SCREW WAS CRUSHED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400692 ↗
• MalfunctionMay 26, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY ACL, THE SCREW BIOSURE REGENESORB BROKE AFTER BEING SCREWED IN TWICE. THE FRAGMENTED PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINAL DRILLED BONE HOLE, USING A DRILL AND TAP TO PREPARE THE INSERTION SITE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084643 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE BIOSURE SCREW BROKE WHEN IT WAS INSERTED INTO THE JOINT, BEFORE TOUCHING THE FEMORAL BONE TO SECURE THE BONE PLUG. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027336 ↗
• MalfunctionNov 20, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, AFTER SEVERAL TURNS OF THE BIOSURE REGENESORB SCREW WERE PASSED, A "CRUNCH" NOISE WAS HEARD AND SCREWING STOPPED. IT WAS THEN OBSERVED THAT THE SCREW BROKE, THE PIECES WERE REMOVED IN AN ATTEMPT TO RECOVER MOST OF THE IMPLANT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20733792 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW GOT BROKEN WHEN SCREW IN. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT USING A GRASPER. THERE WAS A DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20082186 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BIOSURE REGENESORB SCREW BROKE AFTER 2-3 TURNS IN THE TUNNEL. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING GRASPER AND SUCTION. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689021 ↗
• MalfunctionMay 27, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE BIOSURE SCREW BROKE IN HALF AT THE MOMENT OF INSERTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400939 ↗
• MalfunctionJan 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIOSURE REGENESORB BROKE OUTSIDE WHEN IT WAS SCREWED IN. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN THE SAME ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489037 ↗
• MalfunctionOct 4, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE THREADS OF THE BIOSURE SCREW BROKE DOWN WHILE SCREWING INTO THE TIBIAL TUNNEL. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17871359 ↗
• InjurySep 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, AN S+N INTERFERENCE SCREW (B)(4) WAS BEING USED TO FIXATE THE GRAFT IN THE FEMORAL END; HOWEVER, THE DIRECTION OF THE SCREW CHANGED AND THE GRAFT COULD NOT BE FIXED. THEN, A BIOSURE SCREW (B)(4) WAS USED BUT IT BROKE AS IT WAS BEING INSERTED THROUGH THE FEMORAL TUNNEL. A PORTION OF THE SCREW REMAINED INSIDE THE TUNNEL AND WOULDN¿T ALLOW TO REPOSITION THE GRAFT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17684886 ↗
• MalfunctionAug 21, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE WHEN THE SCREW WAS INSERTED WITH THE DEDICATED SCREWDRIVER, THE SCREW BIOSURE BROKE INTO TWO PARTS INSIDE THE KNEE; THE BROKEN PARTS WERE REMOVED. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592364 ↗
• MalfunctionAug 4, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE GOT BROKEN IN TWO PARTS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17459006 ↗
• MalfunctionJul 28, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION TIBIA FIXATION, THE SCREW BIOSURE WAS BROKEN WHEN SCREWING IN THE TUNNEL. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY 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 17418052 ↗
• InjuryOct 18, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW BROKE DOWN. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626925 ↗
• InjuryMay 24, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE TIP OF THE BIOSURE REGENESORB SCREW GOT BROKEN WHILE SCREWING IT INTO THE BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491482 ↗
• MalfunctionOct 31, 2021Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT IN AN ACL TIBIA FIXATION, THE BIOUSURE SCREW WOULD NOT THREAD INTO THE TUNNEL, IT KEPT SPINNING AND WOULD NOT ENGAGE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12725744 ↗
• InjuryOct 11, 2021Break; Break

  IT WAS REPORTED THAT, WHILE SCREWING, INSIDE THE PATIENT, THE SCREW BIOSURE REGENESORB 10MM X 25MM BROKE IN THE TIBIAL TUNNEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12611492 ↗
• InjuryOct 6, 2021Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BIOSURE SCREW BROKE WHILE SCREWING INSIDE THE TIBIAL TUNNEL. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583655 ↗
• InjuryOct 1, 2021Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THREE BIOSURE SCREWS COULD NOT BE FIXATED. ONE SCREW WAS REMOVED, AND WHILE IT WAS REINSERTED THE THREAD BROKE, ALL PIECES WERE REMOVED USING TWEEZERS. THE OTHER TWO SCREWS WERE SUCCESSFULLY FIXATED, AFTER SEVERAL ATTEMPTS, WITHOUT FURTHER PROBLEMS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY GREATER THAN 30 MINUTES, WITH AN SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12565749 ↗
• InjuryAug 18, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN INSERTING THE BIOSURE REGENESORB SCREW INTO THE TIBIAL TUNNEL, WHEN IT WAS BEING FINISHED, ADJUSTING THE SCREWDRIVER TURNED AND THE SCREW BROKE INSIDE THE CHANNEL. WHEN REMOVING THE SCREWDRIVER THE HEAD OF THE SCREW REMAINED STUCK, THE REMAINS WERE REMOVED FROM THE PATIENT WITH THE HELP OF A KELLY FORCEPS, OTHER PIECES CAME OUT ON THEIR OWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339423 ↗
• InjuryAug 9, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL BTB, WHEN THE BIOSURE REGENESORB SCREW WAS PLACED IN THE TUNNEL OF THE TIBIA, IT WAS VERY TIGHT AND FOR THIS REASON THE SCREW BROKE. THE PIECES WERE REMOVED WITH A PICK-UP. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297809 ↗
• InjuryApr 16, 2021Break; Break

  IT WAS REPORTED THAT WHILE INSERTING THE BIOSURE SCREW, IT BROKE. IT IS UNKNOWN IF THERE WAS A BACK UP AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY OR FURTHER 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 11681141 ↗
• InjuryApr 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE BIOSURE SCREW BROKE WHILE FIXING. NO DELAY AND A BACK UP WAS AVAILABLE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11625585 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142948. One submission often covers many models, so check the product and lot details in each record.

• Z-0957-2026 · Nov 24, 2025 · Open, Classified
  BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.