BIOSURE 72204401Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00885554036770), received between Oct 23, 2017 and Apr 18, 2026 — classified as 16 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, ONE (1) BIOSURE REGENSORB SCREW BROKE DURING INSERTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919771 ↗
• MalfunctionApr 5, 2026Crack

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE REGENESORB SCREW CRACK WHEN IMPLANTED. THE ANCHOR WAS REMOVED FROM INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP. IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24787013 ↗
• InjuryMar 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, A PATIENT IN WHICH A BIOSURE REGENESORB INTERFERENCE SCREW WAS IMPLANTED, DEVELOPED PAIN AFTER A CERTAIN PERIOD OF TIME, AND A PORTION OF THE SCREW BECAME PALPABLE BENEATH THE SKIN. OVER TIME, THE SCREW APPEARED TO GRADUALLY BACK OUT FROM ITS ORIGINAL POSITION. ON (B)(6) 2026, THE PATIENT UNDERWENT AN OPERATION TO REMOVE THE SCREW CRUMBS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Inadequate Osseointegration; Pain; Subcutaneous Nodule

  MAUDE report 24490394 ↗
• MalfunctionDec 2, 2025Break; Difficult to Insert; Separation Failure; Break; Difficult to Insert; Separation Failure

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, IT WAS NOTICED THAT WHEN ONE (1) UNIT OF THE SCREW BIOSURE REGENESORB 8MM X 30MM WAS BEING INSERTED, THE THREAD WAS DIFFICULT TO ENGAGE WITH THE TIBIAL TUNNEL AND SOFT TISSUE GRAFT, EXCESSIVE EFFORT WAS NECESSARY TO GET THE SCREW TURNING. ONCE IT WAS INSERTED, THE DRIVER WAS UNABLE TO BE DISENGAGED, AND THE ENTIRE SCREW CAME OUT. THE INSERTION SITE WAS PREPARED WITH A 8MM ACL REAMER USED TO PREPARE TIBIAL ACL TUNNEL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693876 ↗
• MalfunctionSep 30, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, A SCREW BIOSURE REGENESORB 8MM X 30MM WAS PLACED SUCCESSFULLY, HOWEVER, WHEN THE WIRE WAS REMOVED AND THE DRIVER REENGAGED FOR FINAL TIGHTENING THE SCREW FELL APART INTO MULTIPLE PIECES. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23181793 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, WHEN THE DOCTOR WAS INSTALLING THE BIOSURE SCREW, THE TIP BROKE. THE SURGEON WAS ABLE TO EXTRACT THE BROKEN TIP FROM PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. THE BACK UP WAS USED IN THE ORIGINALLY DRILLED BONE HOLE SO NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587327 ↗
• MalfunctionJul 10, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE REGENESORB SCREW STARTED TO BREAK AS SOON AS THE SURGEON BEGAN TO TAP IT INTO THE PATIENT'S BONE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22473704 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE BIOSURE SCREW GOT BROKEN DURING APPLICATION. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22391687 ↗
• MalfunctionApr 19, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE BIOSURE REGENESORB SCREW WAS BROKEN WHEN SCREWING IN. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, AND NO VOID WAS LEFT IN THE PATIENT. THE PATIENT STATUS IS NORMAL AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870077 ↗
• InjuryApr 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, WHILE INSTALLING A REGENESORB SCREW USING A BIOSURE SCREWDRIVER, THE SCREW BROKE. ONE PART OF THE SCREW REMAINED IN THE PATIENT¿S BONE AND WAS NOT EXTRACTED; IT WAS LEFT IN THE BONE. THE SECOND PART OF THE SCREW REMAINED ATTACHED TO THE SCREWDRIVER. THE BACKUP SCREW WAS IMPLANTED NEAR THE BROKEN SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 19187949 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION (TIBIAL FIXATION), THE BIOSURE REGENESORB SCREW WAS BROKEN INTO PIECES. ALL PIECES WERE RETRIEVED FROM THE PATIENT USING GRASPERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE SO NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619977 ↗
• MalfunctionJan 25, 2024Break; Break

  IT WAS REPORTED THAT DURING A ACL SURGERY, THE BIOSURE SCREW BROKE WHEN IT WAS BEING INSERTED. THE SCREW AND ALL THE BROKEN PIECES WERE REMOVED WITH GRASPER, FORCEPS AND SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N 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 18581502 ↗
• MalfunctionSep 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT AN DURING AN ACL RECONSTRUCTION USING THE SCREW-SCREW TECHNIQUE, WHEN PLACING THE FIRST SCREW BIOSURE REGENESORB WHICH WAS THE FEMORAL, THE SCREW ENTERED THROUGH THE TUNNEL AND FIXED THE 8MM TUNNEL´S GRAFT, IT WAS THEN INTENDED TO PROCEED TO FIX THE TIBIAL; HOWEVER THE PHYSICIAN FELT THAT THE GRAFT WAS LOOSE; WHEN IT WAS REVIEWED, IT WAS FOUND THAT THE SCREW WAS FRACTURED AND HAD TO BE REMOVED IN PARTS. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY OF 15 MINUTES WITH A BACK-UP DEVICE. PATIENT´S HEALTH WAS NOT AFFECTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17676769 ↗
• MalfunctionAug 21, 2023Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR AN ACL RECONSTRUCTION PROCEDURE, THE TIP OF THE BIOSURE REGENESORB SCREW WAS BROKEN WHEN OPENED. A BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE AND A NON SIGNIFICANT DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17591908 ↗
• MalfunctionApr 13, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHILE SECURING A GRAFT, A BIOSURE SCREW SHATTERED. ALL PIECES WERE REMOVED FROM THE PATIENT USING HANDS AND SURGICAL INSTRUMENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMALLER SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732275 ↗
• InjuryMar 6, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE ANCHOR BROKE WHEN IT WAS BEING SCREWED INTO THE BONE TUNNEL. ALL THE PIECES WERE MOVED USING A BIOSURE SCREWDRIVER AND TWEEZER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE TUNNEL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16491524 ↗
• InjuryApr 25, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE SCREW BIOSURE REGENESORB BROKE OFF DURING THE DEPLOYMENT. THE BROKEN PIECES WERE REMOVED BY ARTHROSCOPY INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197985 ↗
• InjuryApr 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, THE BIOSURE SCREW BROKE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY BUT IT IS UNKNOWN HOW. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14037348 ↗
• InjuryMar 13, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY USING THE SEMI-T AND GRACILIS, THE SURGEON WAS ATTEMPTING TO USE A SCREW FIXATION FOR THE TIBIAL TUNNEL. THE GRAFT WAS 9MM AND THE TUNNEL WAS DRILLED TO 9MM. AFTER CORRECTLY LOADING THE BIOSURE SCREW ON A BISOURE RACHET DRIVER AND ADVANCING DOWN A 1.2MM GUIDE WIRE, THE BASE OF THE ANCHOR SNAPPED OFF WHEN ATTEMPTING TO INSERT. ALL THE FRAGMENTS WERE RECOVERED FROM THE PATIENT USING GILLIES. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13754007 ↗
• InjurySep 2, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE SCREW BROKE WHILE SCREWING IN, IT WAS SCREWED EFFORTLESSLY. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12418543 ↗
• InjuryAug 26, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A SCREW BIOSURE REGENESORB 8MM X 30MM BROKE WHILE BEING SCREWED IN. ALL PIECES WERE RECOVERED. NO SIGNIFICANT DELAY AND A BACK UP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371578 ↗
• InjuryAug 23, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE "8MM X 30° BIOSURE REGENESORB SCREW" BROKE WHILE BEING EFFORTLESSLY SCREWED IN. ALL THE PIECES WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING ANOTHER SCREW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356091 ↗
• InjuryJun 29, 2021Break; Break

  IT WAS REPORTED THAT THE BIOSURE REGENESORB SCREW BROKE WHILE INSERTING IT INTO THE TIBIA DURING TIBIAL FIXATION OF ACL GRAFT. THE INSERTION SITE HAD BEEN PREPARED WITH A 7MM S&N INSTRUMENTATION SET. GRAFT TYPE WAS SEMITENDINOSUS & GRACILIS. GRAFT SIZE WAS 7MM THICK & 9 CM LONG. TUNNEL SIZE WAS 7MM THICK. BROKEN PIECES WERE RETRIEVED WITH A GRASPER. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE IN THE SAME BONE HOLE. THERE WAS A DELAY OF LESS THAN OR EQUAL TO 30 MIN AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12088713 ↗
• InjuryApr 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE BIOSURE REGENESORB SCREW BROKE ON THE TIP. 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 11741509 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED AFTER 8 MONTHS DUE TO A PATIENT'S ACCIDENT WHERE THE CRUCIATE LIGAMENT TORE AGAIN. DURING SURGERY IT WAS DISCOVERED THAT THE SCREW WAS VIRTUALLY NO LONGER PRESENT, IT WAS A GEL/RUBBER-LIKE SUBSTANCE THAT HAD TO BE REMOVED WITH A SHARP SPOON. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE. NO SIGNIFICANT DELAYS OCCURRED. PATIENT OUTCOME IS UNKNOWN. 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 11064694 ↗

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.