BIOSURE 72204399Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00885554036756), received between Dec 27, 2017 and May 27, 2026 — classified as 13 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Fracture

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, A NITINOL GUIDE WIRE WAS INSERTED, THE HOLE WAS PREPARED WITH A 9.0 DRILL BIT AND TAPPED WITH AN 8 MM TAP, AND A BIOSURE SCREW WAS INSERTED; UPON TIGHTENING, THE SCREW FRACTURED INTO MULTIPLE PIECES. THE BROKEN PIECES WERE REMOVED USING KELLY TWEEZERS. PART OF THE SCREW REMAINED IN THE BONE HOLE. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, USING A COMPETITOR DEVICE IN AN ADDITIONALLY DRILLED BONE HOLE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 25295992 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, A BIOSURE REGENESORB SCREW BROKE DURING FIXATION ON THE FEMORAL SIDE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25030048 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, A BIOSURE REGENESORB SCREW BROKE DURING FIXATION ON THE FEMORAL SIDE. IT IS UNKNOWN HOW THE PROCEDURE WAS PERFORMED OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024851 ↗
• MalfunctionApr 15, 2026Break; Material Deformation

  IT WAS REPORTED THAT DURING AN ACL SURGERY, A 9 MM TIBIA ENDOSCOPY DRILL BIT WAS USED FOR TIBIA TUNNEL. WHILE INSERTING ONE (1) BIOSURE REGENESORB SCREW AT THE TIBIA TUNNEL, THE SCREW THREAD GOT DAMAGED AND THE SCREW BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP. 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 24886354 ↗
• MalfunctionSep 18, 2025Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING ACL SURGERY, WHILE THE BIOSURE REGENESORB SCREW WAS BEING INSERTED AT THE TIBIA TUNNEL, THE THREADS GOT DAMAGED; A 7MM TIBIA ENDOSCOPY DRILL BIT WAS USED FOR THE TIBIA TUNNEL, AND THE SURGERY WAS COMPLETED USING A BACKUP DEVICE AFTER A SURGICAL DELAY OF LESS THAN 30 MINUTES, WITH NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23089126 ↗
• InjuryJun 16, 2025Break; Break

  IT WAS REPORTED THAT AFTER AN ACL, LCL SURGERY ON (B)(6) 2024, WITH ALLOGRAFT (ACHILLES TENDON) USED (ALLOGRAFT WITH BONE AND THE BIOSURE SCREW WERE USED FOR FEMUR), THE PATIENT CAME BACK LAST WEEK COMPLAINING ABOUT A LOOSE BODY IN THE KNEE. THE PATIENT UNDERWENT KNEE SCOPE AND IT WAS FOUND THAT THE FRONT PART OF THE SCREW WAS BROKEN AND THE LOOSE PIECE WAS FLOATING IN THE KNEE. ALL THE BROKEN PIECES WERE REMOVED FORM THE PATIENT USING FORCEPS. THERE WAS NO BACK UP USED. THERE WAS NO DELAY ON THE KNEE SCOPE. THE ACL OF THE PATIENT WAS INTACT AND FINE.

  Patient problems: Discomfort

  MAUDE report 22214546 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW BROKE DURING SCREWING. ALL THE ELEMENTS WERE REMOVED. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261113 ↗
• MalfunctionOct 22, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, WHEN THE SURGEON WAS FIXATING THE ACL GRAFT IN THE TIBIAL TUNNEL WITH A BIOSURE REGENESORB SCREW, IT BROKE APART. ALL PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT. 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 20508100 ↗
• MalfunctionMay 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIOSURE REGENESORB TIP GOT BROKEN WHILE SCREWING INTO THE BONE, THE BROKEN PIECES WERE REMOVED FROM THE BONE WITH THE HELP OF GRASPER. THE PROCEDURE WAS COMPLETED USING A SMIT AND NEPHEW BACKUP 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 19425855 ↗
• MalfunctionApr 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE BIOSURE SCREW WAS INSERTED, IT SPLIT, LEAVING 1 CM INSIDE AND THE REST OUTSIDE THE FEMORAL TUNNEL. AN ATTEMPT WAS MADE TO REMOVE THE BROKEN PIECE, HOWEVER, IT WAS IMPOSSIBLE, IT WAS THE DECIDED TO LEAVE IT INSIDE THE PATIENT, SINCE BY FORCEFULLY REMOVING IT, THE GRAFT COULD BE DAMAGED. SURGERY WAS COMPLETED BY CHANGING THE SURGICAL TECHNIQUE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19038886 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE BIOSURE REGENESORB SCREW BROKE WHEN IT WAS BEING SCREWED IN. 3/4 OF THE SCREW REMAINED IN THE PATIENT'S KNEE. NO OTHER SCREW WAS FITTED BECAUSE IT WAS IMPOSSIBLE TO FIT ANOTHER SCREW IN THE SAME TUNNEL. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18838806 ↗
• InjurySep 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, TWO (2) BIOSURE SCREW FRACTURED DURING PLACEMENT IN THE FEMORAL TUNNEL, DUE TO THE HARDNESS OF THE PATIENT'S BONE, MOST OF THE PRODUCTS WERE REMOVED, BUT SOME FRAGMENTS MAY HAVE REMAINED. SURGERY WAS COMPLETED AFTER A SIGNIFICANT DELAY, USING BACK-UP DEVICES INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17803755 ↗
• MalfunctionSep 11, 2023Break; Break

  IT WAS REPORTED THAT DURING A LEFT KNEE LIGAMENT REPAIR SURGERY; AFTER THE GRAFT WAS PASSED THROUGH BOTH TUNNELS (FEMUR AND TIBIA) AND IT WAS PROCEEDED TO FIX THE FEMUR BY PLACING THE NITINOL GUIDE AND PROCEEDED TO PASS THE MALE 8MM AND THE BIOSURE SCREW WITH THE RACHE HANDLE; WHEN THE SCREW HAD ADVANCED HALF THE LENGTH INTO THE BONE; IT GOT BROKEN. THE PHYSICIAN RETIRED THE SCREWDRIVER AND NITINOL GUIDE AND PROCEEDED TO REMOVE THE TOTALLY OF THE BIOSURE´S FRAGMENTS. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY OF 5 MINUTES; BY PLACING THE NITINOL GUIDE AND THE NEW BIOSURE SCREW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725603 ↗
• MalfunctionJul 21, 2023Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE BIOSURE SCREW BROKE WHEN IT WAS SCREWED INTO THE PATIENT. IT WAS POSSIBLE TO EXTRACT THE BROKEN PIECE. SURGERY WAS COMPLETED USING A BACK-UP DEVICE INSTEAD, A DELAY WAS REPORTED, HOWEVER, IT IS UNKNOWN IF IT WAS SIGNIFICANT. NO CONSEQUENCES OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375350 ↗
• InjuryMar 1, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING AN ACL BTB RECONSTRUCTION PROCEDURE, AFTER PLACING THE BIOSURE SCREW WHEN GIVING IT TRACTION THE GRAFT MOVED AND IT WAS DECIDED TO CHANGE THE DEVICE FOR A LARGER ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461551 ↗
• MalfunctionSep 23, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A KNEE SCOPE, WHEN A BIOSURE REGENESORB WAS OPENED INTO THE STERILE FIELD, IT GOT STUCK INTO THE PACKAGE, WHEN LOOKED AT IT CLOSELY IT WAS NOTICED THAT THE PACKAGE HAD A PINPRICK HOLE, THEREFORE THE PRODUCT WAS NON STERILE. 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 15470326 ↗
• InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO YEARS AFTER AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY OF THE RIGHT KNEE PERFORMED WITH A BIOSURE REGENESORB SCREW AND ARTHERX FIXATION, A PATIENT WAS HOSPITALIZED DUE TO PAIN AND DISCOMFORT NEAR THE INCISION FOR THREE MONTHS. THE PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY TO REMOVE THE ARTHREX FIXATION. THE PATIENT RECOVERED WITHOUT SEQUELAE.

  Patient problems: Discomfort; Pain

  MAUDE report 15464885 ↗
• InjuryApr 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE HEAD OF THE BIOSURE SCREW FRACTURED WHILE ENDING THE INTRODUCTION OF THE DEVICE INTO THE FEMORAL TUNNEL. AFTER SOME TESTS, IT WAS CONFIRMED THAT THE BODY OF THE SCREW HAD GOOD FIXATION TO THE GRAFT AND THE TUNNEL, THEREFORE, IT WAS DECIDED TO LEAVE THE REST OF THE SCREW INSIDE OF THE TUNNEL. THE SCREW HEAD WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH FIVE MINUTES OF DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138817 ↗
• InjuryMar 10, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE SCREW BROKE IN INSERTION. NON-SIGNIFICANT DELAY WAS REPORTED. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725732 ↗
• InjuryFeb 1, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN AN UNSPECIFIED PROCEDURE, THE BIOSURE REGENSORB SCREW BROKE WHILE DEPLOYING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13416420 ↗
• InjuryJan 3, 2022Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN INSERTING THE SCREW IN THE TUNNEL, THE SCREW GOT BROKEN. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142469 ↗
• InjuryOct 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER FIVE MONTHS OF AN ACL REPAIR SURGERY ON A LEFT KNEE WITH A BIOSURE REGENESORB SCREW, THE PATIENT PRESENTED A SLIGHT SWELLING OF THE LEFT KNEE JOINT. THE SWELLING WAS RESOLVED WITH MEDICATION IN APPROXIMATELY TWO MONTHS.

  Patient problems: Swelling/ Edema

  MAUDE report 12602491 ↗
• InjuryAug 13, 2021Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317213 ↗
• InjuryJun 13, 2021Break; Break

  IT WAS REPORTED, THAT DURING AN ACL CASE, THE BIOSURE REGENESORB SCREW BROKE DURING THE INSERTION TO THE FEMUR TUNNEL. THE PROCEDURE WAS COMPLETED WITH A 30 MINUTE DELAY USING ANOTHER SIZE OF BIOSURE REGENESORB. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988857 ↗
• MalfunctionJan 6, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL REPAIR PROCEDURE, WHILE DRIVING THE "8MM X 25MM BIOSURE REGENESORB SCREW" IN THE TUNNEL TO FIX THE GRAFT, IT BROKE IN SMALL PIECES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO 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 11124720 ↗

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.