BIOSURE 72204409Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00885554036855), received between Nov 25, 2017 and Oct 15, 2025 — classified as 16 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (31 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, IT WAS NOTICED THAT THE SCREW BIOSURE REGENESORB WAS BROKEN. THE BROKEN PARTS WERE COMPLETELY REMOVE FROM THE PATIENT USING A HAND INSTRUMENT. THE PROCEDURE WAS PERFORMED WITHOUT ANY SURGICAL DELAY, USING A SIMILAR S+N BACK-UP PRODUCT, USING THE ORIGINAL DRILLED BONE HOLE AND LEAVING NO VOID IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23288624 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIOSURE REGENESORB BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED USING AN SN BACKUP DEVICE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935077 ↗
• MalfunctionJul 25, 2025Break; Break

  IT WAS REPORTED THAT THE SCREW BIOSURE REGENESORB 10MM X 30MM WAS FOUND TO BE BROKEN. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WAS A DELAY. THERE WAS A BACK-UP DEVICE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22604449 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BIOSURE REGENESORB SCREW BROKE. BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH HAND INSTRUMENT. 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 21905612 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY ACL RECONSTRUCTION SURGERY, WHEN THE SCREWDRIVER WAS REMOVED, THE PROXIMAL HALF OF THE BIOSURE SCREW CAME OUT WITH THE DRIVER. THE BIOSURE SCREW WAS BROKEN IN HALF. THE DISTAL PART OF THE BIOSURE REGENESORB WAS LEFT IN THE PATIENT¿S TIBIA, THE PROXIMAL PART OF THE SCREW WAS REMOVED WITH TWEEZER FROM PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SURGICAL TECHNIQUE; THE DISTAL BROKEN PART OF THE SCREW HELD THE GRAFT IN TIBIA TUNNEL WITH FAIR BITING FORCE AND THE SURGEON REINFORCED THE HOLDING STRENGTH BY SECURING THE REMAINING GRAFT AND SUTURED WITH A CORTICAL SCREW AND WASHER ON A SEPARATE SITE MORE DISTAL TO THE TIBIA TUNNEL END. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21106170 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE BIOSURE REGENESORB SCREW WAS BROKEN WHILE IT WAS BEING INSERTED INTO THE PILOT HOLE. THE 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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21105488 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW BROKE WHILE INSERTING IT INTO THE TIBIA. THE PIECES WERE REMOVED FROM THE PATIENT USING A TWEEZERS AND SUCTION. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY BONE HOLE. 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 20747676 ↗
• MalfunctionOct 22, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING AN ACL, THE INTERNAL THREAD OF THE SCREW BIOSURE REGENESORB DID NOT CATCH WITH THE SCREWDRIVER. THE PROCEDURE WAS COMPLETED USING A SCREW OF THE SAME SIZE IN A NEW DRILLED BONE HOLE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 20505946 ↗
• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED THAT ACL SURGERY, THE BIOSURE REGENESORB SCREW WAS BEING FIXED ON THE TIBIAL AREA, IT WAS NOTICED THAT IT BECAME LOOSE AND A CLICK SOUND WAS HEARD. THE SCREW WAS REMOVED AND IT WAS NOTICED THAT THERE WERE BROKEN EDGES ON THE SCREW. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 19757115 ↗
• MalfunctionJan 18, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE BIOSURE REGENESORB SCREW BROKE WHEN SCREWING INTO TIBIAL TUNNEL. ALL THE PIECES WERE REMOVED FROM PATIENT USING THE BIOSURE SCREWDRIVER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18539396 ↗
• MalfunctionJan 8, 2024Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE THREADS OF THE SCREW BIOSURE REGENESORB WERE BENDING WHEN THEY GOT IN CONTACT WITH TISSUE. THE SCREW WAS REMOVED. AN INSTRUMENT OF 8MM WAS USED TO PREPARE THE SITE BEFORE INSERTION ATTEMPT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. AS PER INVESTIGATION RESULTS, IT WAS FOUND THE DEVICE IS FRACTURED APPROXIMATELY 1/3 OF THE WAY DOWN FROM THE DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18469395 ↗
• MalfunctionOct 26, 2023Break; Break

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR A ACL RECONSTRUCTION TIBIAL FIXATION, THE BIOSURE SCREW WAS DAMAGED UNDER VISUAL INSPECTION, SOME THREADS ARE OBSERVED AS BROKEN. 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 18014656 ↗
• MalfunctionOct 17, 2023Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE REGENESORB DID NOT FIT COMPLETELY IN THE BONE HOLE WHEN ATTEMPTING TO ANCHOR USING THE RATCHET SCREWDRIVER. IT WAS RETRIEVED AND A SECOND ATTEMPT TO ANCHOR THE SCREW IN THE TIBIA WAS PERFORMED USING A THREAD TAP; HOWEVER, THE ANCHOR BROKE. ALL FRAGMENTS WERE RETRIEVED FROM THE JOINT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951210 ↗
• MalfunctionApr 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL, THE BIOSURE SCREW BROKE WHILE INSERTION INTO THE TIBIA. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS AND SUCTION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817285 ↗
• MalfunctionJan 5, 2023Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW GOT BROKEN DIRECTLY BY PLACING, THE DEVICE DID NOT BREAK, BUT DISTORTED. THE SCREW WAS SPINNING AND REMOVED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. THE BONE QUALITY WAS NORMAL. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS NO VOID LEFT IN THE PATIENT. THE INSTRUMENT USED TO PREPARE THE INSERTION SITE WAS A 9.5 CANN DRILL BIT SIZE AND THE TUNNEL SIZE WAS 9,5. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. THE PATIENT STATUS HAD A NORMAL RECOVERY. THE SURGEON WAS ULTIMATELY SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16103054 ↗
• InjuryOct 31, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE BIOSURE REGENESORB SCREW BROKE DOWN DURING FIXATION. THE SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697884 ↗
• InjuryOct 27, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW WAS DAMAGED DURING THE IMPLANTATION, IT MADE CRACKING SOUND AND BROKE DOWN. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. NOT ALL DAMAGED PARTS COULD BE SALVAGED BY SURGEON THUS HE ADDED TWO STAPLES TO HOLD THE TENSION. NO VOID, JUST REMAINS OF DAMAGED SCREW KEPT IN THE TIBIAL TUNNEL. INSTRUMENT USED TO PREPARE THE INSERTION SITE WAS: ACUFEX LP CANNULATED DRILL BIT. INSTRUMENT SIZE WAS 9MM. TUNNEL¿S SIZE WAS 9MM. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS. THE SURGEON WAS NOT QUITE SATISFICED WITH THE SURGICAL OUTCOME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15681965 ↗
• InjuryJul 29, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIOSURE BROKE INTO PIECES AND WAS NOT RETRIEVABLE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY AND WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15131208 ↗
• InjuryJun 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIOSURE SCREW FRACTURED AND BROKE INTO TWO PIECES AS THE SURGEON SCREWED IT HALF WAY INTO THE TIBIAL TUNNEL. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH BIOSURE DRIVER. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT STATUS OF THE PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14750780 ↗
• InjuryApr 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE 'BIOSURE REGENESORB' SCREW BROKE DOWN DURING FIXATION. A SURGICAL DELAY GREATER THAN 30 MINUTES WAS REPORTED, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14161727 ↗
• InjuryJan 17, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN PLACING THE BIOSURE REGENESORB, IT DID NOT ADVANCED, UPON CHECKING IT WAS FOUND THAT IT GOT FRACTURED. THE PROCEDURE WAS COMPLETED WITH A NON SIGNIFICANT DELAY USING A BACK-UP DEVICE. PIECES WERE REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266271 ↗
• InjuryDec 14, 2021Break; Break

  IT WAS REPORTED THAT DURING ACL PROCEDURE, INTERNAL TO PATIENT, THE SCREWS FAILED TO BE PLACED, IT WAS DAMAGED AT THE TIME OF SCREWING, THERE WAS A SOUND AND THE SCREWDRIVER WAS REMOVED WITH A PART OF THE SCREW, THE REMAINING BROKEN PIECES WERE REMOVED USING PLIERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003137 ↗
• InjuryDec 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING A KNEE SURGERY, AT THE TIME THE INZQUIOTIBIAL TENDON, IT WAS GOING TO BE ATTACHED TO THE TIBIA THROUGH THE TUNNEL, THE BIOSURE REGENESORB SCREW BROKE IN HALF. THE BROKEN PIECE REMAINED INSIDE THE PATIENT AND THE FUNCTION OF PLACING THE INSERT WAS FULFILLED, SO IT WAS NOT NECESSARY TO PLACE ANOTHER SCREW. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12986807 ↗
• InjuryNov 19, 2021Break; Break

  IT WAS REPORTED THAT DURING A LCA SURGERY, THE BIOSURE REGENESORB SCREW BROKE INSIDE OF THE PATIENT WHEN THE SURGEON FORCED THE TUNNEL IN A NON PARALLELABLE DIRECTION TO THE GUIDEWIRE. THE DISTAL PART OF THE BIOSURE WAS REMOVED WITH TWEEZER, WHILE THE PROXIMAL WAS LEFT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A SCREW FROM AN UNKNOWN COMPETITOR. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846747 ↗
• InjurySep 7, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN UNSPECIFIED PROCEDURE, THE SCREW BROKE IN ITS DISTAL PART WHEN IT WAS PUT IN PLACE. THE PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER BACKUP SCREW. IT IS UNKNOWN IF THERE WAS A DELAY. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434495 ↗

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.