BIOSURE 72204404Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00885554036800), received between May 27, 2019 and May 31, 2026 — classified as 6 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL REPAIR, A BIOSURE SCREW BROKE DURING INSERTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25344143 ↗
• MalfunctionMar 31, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN ACL SURGERY, AN 8 MM DIAMETER HAMSTRING GRAFT WAS PREPARED AND A 9 MM TIBIAL ENDOSCOPY DRILL BIT WAS USED FOR THE TIBIAL TUNNEL. WHILE INSERTING A 9 MM × 25 MM BIOSURE REGENESORB SCREW INTO THE TIBIAL TUNNEL, THE SCREW THREADS BECAME DAMAGED. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24750667 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION WITH ALLOGRAF WITH BONE BLOCK, FEMORAL BONE BLOCK SIZED AS 10MM, DRILLED AN 11MM FEMORAL TUNNEL AND DECIDED TO USE ONE (1) BIOSURE RG SCREW AS SECONDARY FIXATION TO THE ULTRABUTTON BB AND SCREW BROKE ON INSERTION. THE BROKEN PART WAS REMOVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A METAL RCI SCREW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24725749 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW BROKE DURING INSERTION. SURGERY WAS COMPLETED USING A SMITH & NEPHEW 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 22709815 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY AN 8MM ENDOSCOPY DRILL GUIDE WAS USED FOR THE TIBIA TUNNEL DRILLING AND THE BIOSURE REGENESORB SCREW'S THREAD GOT BROKEN WHILE INSERTING THE SCREW AT TIBIA TUNNEL. 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 20544626 ↗
• MalfunctionOct 4, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHILE SCREWING IN THE TIBIAL TUNNEL, THE BIOSURE REGENESORB SCREW THREADS WERE DAMAGED AND BROKEN. 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 20369851 ↗
• MalfunctionJul 5, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF A BIOSURE REGENESORB SCREW BROKE OFF AS THE SURGEON WAS INSERTING IT INTO THE TIBIAL TUNNEL. 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 19679830 ↗
• MalfunctionMay 21, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE CROSS LIGAMENT RECONSTRUCTION, THE BIOSURE ANCHOR BROKE WHEN IT WAS MIDWAY THROUGH INSERTION. THE FRAGMENTS WERE REMOVED USING KELLY FORCEPS. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY 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 19365162 ↗
• MalfunctionMay 7, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE SCREW BIOSURE WAS SCREWED INTO THE FEMUR, IT BROKE. 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. NO DAMAGE CAUSED, THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260396 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE BIOSURE ANCHOR BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH AN ARTHREX 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 18616998 ↗
• MalfunctionFeb 28, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, A SCREW BIOSURE REGENESORB GOT BROKEN. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453374 ↗
• InjuryMar 23, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE 'BIOSURE REGENESORB' SCREW BROKE WHILE SCREWING IN. THE BROKEN PIECES WERE REMOVED FROM THE BONE WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865963 ↗
• InjuryJan 5, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BIOSURE REGENESORB BROKE WHILE INSERTING IN THE 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 13169300 ↗
• MalfunctionOct 21, 2021Break; Break

  IT WAS REPORTED THAT THE ANCHOR BROKE OFF EVEN WHEN IT WAS IN THE RIGHT DIRECTION. THERE WAS A S+N BACK UP DEVICE AVAILABLE. THERE WAS A NON-SIGNIFICANT DELAY REPORTED. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY OR IF IT WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12677319 ↗
• MalfunctionSep 16, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, AFTER SEVERAL ATTEMPTS TO PLACE THE SCREW WITH OTHER POSSIBLE SCREWDRIVERS, THE SCREW BROKE. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A COMPETITOR DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479089 ↗
• MalfunctionAug 4, 2021Break; Break

  IT WAS REPORTED THAT THE SCREW BIOSURE REGENESORB 9MM X 25MM BROKE. IT IS UNKNOWN WHEN THE INCIDENT OCCURRED. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277646 ↗
• InjuryJul 1, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ACL RECONSTRUCTION, THE THREADS OF THE "SCREW BIOSURE REGENESORB" BROKE WHILE INSERTING IN TO TIBIA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE IN THE SAME BONE HOLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12102286 ↗
• InjuryDec 28, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, WHILE SCREWING INSIDE THE TIBIAL TUNNEL THE SCREW BROKE. THIS SCREW WAS SUCCESSFULLY REMOVED FROM PATIENT WITH ARTERY FORCEPS. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT 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 11079335 ↗
• InjuryJul 16, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON IMPLANTED A 9X25 BIOSURE REGENESORB SCREW INTO THE TIBIA AS PART OF AN ACL RECONSTRUCTION WITH NO ISSUES. ON (B)(6) 2020, THE PATIENT WENT TO CLINIC WITH SWELLING, REDNESS AND PAIN AT THE INCISION SITE. THE PATIENT WAS BROUGHT BACK INTO THE OR AND UPON THE INCISION FRAGMENTS OF THE SCREW WERE SEEN. UPON FURTHER DISSECTION, MORE FRAGMENTS OF THE SCREW WERE FOUND AND REMOVED. WITH GUIDANCE OF AN ARTHROSCOPE, THE TIBIAL TUNNEL WAS DEBRIDED OF ALL REMAINING FRAGMENTS AND WASHED OUT. A 10X25 RCI INTERFERENCE SCREW WAS THEN PLACED IN THE TIBIAL TUNNEL IN PLACE OF THE FRAGMENTED BIOSURE REGENESORB INTERFERENCE SCREW. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10286460 ↗
• InjuryMay 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT GRAFT, THE INTERFERENCE SCREW FRACTURED DURING PLACEMENT IN THE FEMORAL TUNNEL. CHANGING THE SCREW WAS IMPOSSIBLE. IT IS UNKNOWN IF THERE WERE DELAYS OR A BACK UP AVAILABLE, AS WELL AS HOW WAS THE SURGERY COMPLETED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 10022847 ↗
• MalfunctionJan 31, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A PROCEDURE SCREW BROKE WHILE SCREWING IN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SIGNIFICANT 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 9654508 ↗
• MalfunctionJan 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY THE BIOSURE REGENSORB SCREW BROKE WHILE IT WAS INSERTED. THERE WAS A BACK-UP DEVICE AVAILABLE. IT IS UNKNOWN IF THERE WAS A SIGNIFICANT DELAY DURING THE PROCEDURE. 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: Foreign Body In Patient

  MAUDE report 9592059 ↗
• MalfunctionSep 25, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A SURGERY, THE DEVICE BROKE IN SEVERAL PIECES WHILE IT WAS BEING IMPLANTED. EACH PIECE WAS REMOVED FROM THE PATIENT WITH TWEEZERS, WHICH RESULTED IN A SURGICAL DELAY GREATER THAN 30 MIN. THERE WAS A BACKUP DEVICE AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9119184 ↗
• MalfunctionJul 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AFTER THE INSERTION OF THE INTERFERENCE SCREW, THE SURGEON EXPLORED ARTHROSCOPICALLY THE TUNNEL, DURING THIS, HE FOUND OUT TWO SMALL PIECES WHICH WERE ACTUALLY BROKEN PARTS OF THE SCREW. THE SURGEON REMOVED THEM AND LET THE SCREW IN PLACE. NO DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8816339 ↗
• MalfunctionJun 7, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A REVISION ACL SURGERY THE OUTER LAYER OF THE SCREW CRUMBLED AS IT WAS HALFWAY IN. ALL THE BROKEN PIECES WERE REMOVED SUCCESSFULLY USING A GRASPER AND NO PRODUCT WAS USED AFTER. NO SIGNIFICANT DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 8679766 ↗

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.