BIOSURE 72204395Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00885554036718), received between Nov 8, 2018 and May 14, 2026 — classified as 10 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Fracture

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY LCA PROCEDURE, THE BIOSURE SCREW FRACTURED AS IT WAS BEING FULLY ADVANCED INTO THE TUNNEL, AFTER THE NITINOL PIN WAS INSERTED AND A 6 MM TAP WAS APPLIED. SOME PARTS WERE RETRIEVE USING KELLY FORCEPS BUT MAJORITY OF THE IMPLANT WAS LEFT IMPLANTED IN THE PATIENT. THE PROCEDURE WAS PERFORMED WITHOUT ANY DELAY, USING THE SAME PRODUCT. PATIENT IS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25172869 ↗
• MalfunctionFeb 26, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL THE BIOSURE SCREW WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24465629 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPIC PROCEDURE, AFTER THE INSERTION SITE WAS CLEARED OF ALL DEBRIS, THE LATERAL COLLATERAL LIGAMENT WAS REINSERTED AND FIXED WITH A 7MM BIOSURE SCREW IN THE FEMORAL CONDYLE. WHEN THE SCREW WAS ADVANCED, IT FRACTURED. ALL PIECES WERE REMOVED FROM THE PATIENT WITH HEMOSTATIC FORCEPS. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE SAME BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED, THE PATIENT'S CONDITION IS STABLE. THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005608 ↗
• MalfunctionSep 23, 2025Break; Fracture; Material Integrity Problem; Break; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN ACL SURGERY, A 6MM DIAMETER HAMSTRING GRAFT WAS PREPARED. A 6MM TIBIA ENDOSCOPY DRILL BIT WAS USED FOR THE TIBIAL TUNNEL, AND WHILE INSERTING THE 7MM X 25MM BIOSURE REGENESORB SCREW INTO THE TIBIAL TUNNEL, THE SCREW THREAD GOT DAMAGED. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PRELIMINARY VISUAL INSPECTION SHOWED THE DISTAL TIP HAS FRACTURED AWAY AND WAS NOT RETURNED. BIO DEBRIS IS PRESENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23123823 ↗
• InjuryJun 30, 2025Break; Break

  IT WAS REPORTED THAT, AFTER AN ARTHROSCOPIC PROCEDURE, IN WHICH A BIOSURE REGENESORB SCREW WAS USED, THE PATIENT RETURNED TO THE SURGEON'S OFFICE AND HAD A POST OP X-RAY TAKEN. THEY NOTICED THAT THE HEAD OF THE SCREW ON THE FEMORAL SIDE HAD BROKEN OFF AND WAS LODGED IN THE FAT PAD IN FRONT OF THE KNEE. PATIENT FELT NO PAIN, BUT IS CONCERNED ABOUT THE ABSORPTION RATES AND POSSIBLE COMPLICATIONS THAT MAY COME WITH A SCREW RESORTING IN THE FAT PAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22359068 ↗
• MalfunctionJan 14, 2025Break; Break

  IT WAS REPORTED THAT DURING A MPFL SURGERY, SCREW BIOSURE REGENESORB BROKE WHILE INSERTING IN THE TUNNEL; ALL THE BROKEN PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN THE SAME ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148500 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE LIGAMENT WAS FIXED IN THE TIBIA THE BIOSURE SCREW FRACTURED. THE BROKEN SCREW WAS ENTIRELY REMOVED USING A GRASPER CLAMP. 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 19727353 ↗
• InjuryFeb 12, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW SNAPPED THE DISTAL 10MM OFF WHILE BEING INSERTED INTO THE ANTEROMEDIAL PORTAL. THE BROKEN PART WAS LEFT EMBEDDED IN THE PATIENT'S TUNNEL AND THE DR FIXED THE GRAFT USING A ZIMMER BIOMET SCREW AT THE FEMORAL CORTEX AND A BIOSURE REGENESORB SCREW AT THE TIBIAL END. AN ADDITIONAL BONE HOLE WAS DRILLED IN THE FEMORAL CORTEX TO IMPLANT THE ZIMMER BIOMET ANCHOR. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 18685205 ↗
• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN PUTTING SCREW BIOSURE ON THE TUNNEL FEMUR, IT BROKE HALFWAY, AND IT HAD TO BE REMOVED. THE SIZE OF THE GRAFT WAS 6, THE REAMER 7, AND REAM 25CM LENGTH. THE PROCEDURE WAS 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 18187010 ↗
• MalfunctionOct 31, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE SCREW BIOSURE BROKE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18040802 ↗
• InjurySep 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A 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 17803692 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE SCREW BIOSURE REGENESORB WAS NOT ENTERING IN THE TUNNEL, WHEN IT ENTERED, IT BROKE IN FRAGMENTS. THE FRAGMENTS WERE REMOVED WITH CURVED KELLY FORCEPS. THE PROCEDURE WAS COMPLETED WITH 2 MINUTES OF 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 17316680 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE BIOSURE SCREW RUPTURED DURING ADVANCEMENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL 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 17083210 ↗
• MalfunctionApr 12, 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 IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS HEALING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725759 ↗
• MalfunctionApr 12, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHILE SECURING A GRAFT, A BIOSURE SCREW WAS ATTEMPTED BUT IT BURST. 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 IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS HEALING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725732 ↗
• InjuryAug 30, 2022Break; Break

  IT WAS REPORTED THAT DURING THE FEMORAL FIXATION PROCEDURE OF THE GRAFT PERFORMED WITH THE BIOSURE REGENESORB SCREW, AFTER INSERTING MORE THAN HALF OF THE SCREW ACCORDING TO THE INSTRUCTIONS FOR USE AND TURNING THE SCREWDRIVER, THE HEAD OF THE SCREW BROKE. THIS HEAD WAS REMOVED FROM THE JOINT WITH THE HELP OF FORCEPS. THE GRAFT WAS TIGHTENED AND IT WAS VISUALIZED THAT THE GRAFT DOES NOT MOVE SO THERE WAS NO NEED TO REMOVE THE SCREW AND REPLACE IT WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY AND WAS FINISHED WITH THE SAME SMITH AND NEPHEW DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 15323428 ↗
• InjuryApr 9, 2022Break; Break

  IT WAS REPORTED THAT DURING A BTB GRAFT ACL RECONSTRUCTION, THE BIOSURE REGENESORB SCREW BROKE INTO PIECES WHEN SCREWING IN. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT BY GASPER AND SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14067681 ↗
• InjuryDec 7, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACHILLES TENDON REPAIR SURGERY, AT THE TIME OF PLACING THE SCREW, THE SCREWDRIVER WAS NOT FOUND INSIDE THE TRAY. THE DOCTOR USED A SCREWDRIVER THAT WAS IN THE HOSPITAL WHICH WAS NOT FROM SMITH+NEPHEW, AND WHEN HE USED IT, THE SCREW BROKE IN HALF. ALL PIECES WERE REMOVED USING A HEMOSTAT AND PICK-UP CLAMP. THE PROCEDURE WAS COMPLETED USING THE OLD SURGICAL TECHNIQUE WHICH CONSISTED IN PASSING THE TENDON THROUGH THE TUNNEL AND PASSING THE SUTURES THAT ARE GRASPING IT AND HAVING EXIT THROUGH THE CALCANEUS, FIXING THE SUTURES TO THE SKIN. THIS IS WHAT IS DONE WHEN THERE IS NO SCREW. A DELAY GREATER THAN 30MIN TOOK PLACE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12955241 ↗
• InjuryNov 7, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A FEMORAL FIXATION OF THE ANTERIOR CRUCIATE LIGAMENT, INTERNAL TO PATIENT, THE 7MMX 25MM BIOSURE REGENESORB WAS USED WITH THE 1.2MM NITINOL GUIDE THAT WAS PASSED, WHICH IS THE SCREW GUIDE AND STEP OF THE SCREW CORRESPONDING TO THE DIAMETER OF THE SCREW, THE SCREW WAS INSERTED WITH GREAT RESISTANCE, BUT THE SCREW WAS NOT ABLE TO INSERT IT IN ITS ENTIRETY, IT WAS INSERTED 80%, THEN THE SCREW WAS REMOVED USING KELLY FORCEPS. THE SCREW WAS PASSED AND THIS SCREW DID NOT ENTER AND IT WAS REMOVED FROM THE JOINT WITH DIFFICULTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A 7MM X 25MM TITANIUM SCREW IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12764169 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE USING THE SCREW BIOSURE REGENESORB, AT THE TIME OF PLACING THE INTERFERENCE SCREW IN THE FEMUR, IT FELT MORE RESISTANT THAN USUAL, AND IT WAS NOTICED THAT THE SCREW BEGAN TO GET ENTANGLED IN THE LIGAMENT TISSUE. WHEN THE FIXATION OF THE TIBIAL SCREW WAS FINISHED, IT WAS EVIDENT THAT MORE THAN HALF OF THE GRAFT GOT ENTANGLED IN THE SCREW. THE SCREW HAD TO BE REMOVED TO PREVENT THE GRAFT FROM BEING DAMAGED AND TO REPOSITION THE GRAFT. THE GRAFT HAD TO BE PULLED VERY HARD, MORE THAN NORMAL, AND IT EVEN FELT LIKE THE SCREW WAS TRYING TO RE-ENTANGLE. THE PROCEDURE WAS FINISHED WITH A DELAY GREATER THAN 30MIN USING THE SAME REPORTED DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12756105 ↗
• InjuryOct 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING ACL RECONSTRUCTION PROCEDURE, THE SCREW BROKE, THE CHANNEL WAS PROPERLY PREPARED, SIZE MATCHED, THE SCREW JUST BROKE DOWN AND WAS REPLACED BY THE NEW ONE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NON-SIGNIFICANT SURGICAL DELAY AND NO PATIENT FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562618 ↗
• MalfunctionJul 13, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE SCREW BIOSURE REGENESORB THREADS BROKE BUT NOTHING FELL INTO PATIENT'S BODY. PROCEDURE FINISHED WITH S&N BACKUP DEVICE, SAME BONE HOLE WAS USED. NO SURGICAL DELAY OR COMPLICATIONS TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162635 ↗
• MalfunctionMay 20, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW HAD A BREAKAGE. THE DEVICE DID BREAK INSIDE THE PATIENT AND ALL THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE PATIENT HAD GOOD BONE QUALITY ALLOWING THE BACK UP DEVICE TO BE USED IN THE ORIGINAL DRILLED BONE HOLE. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO SIGNIFICANT DELAY AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11859615 ↗
• MalfunctionMay 11, 2021Break; Break

  IT WAS REPORTED THAT THE SCREW BIOSURE REGENESORB'S THREAD PEELED OFF FROM THE SCREW. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806877 ↗
• InjuryMay 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER AN ARTHROSCOPIC PROCEDURE FOR AN ACL REPAIR, THE PATIENT HAD A RIGHT KNEE SCOPE POSTOPERATIVE THAT CONFIRMED A GRAFT FAILURE. THE EVENT WAS TREATED WITH PHYSICAL AND MEDICATION THERAPY. THE OUTCOME OF THE PATIENT WAS UNRESOLVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10091592 ↗

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.