BIOSURE 72201769Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 03596010611659), received between Aug 22, 2017 and Mar 7, 2026 — classified as 31 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (44 reports).

2 other recalls cover devices cleared under the same FDA submission (K080358); 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 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2026Fracture

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE BIOSURE ANCHOR FRACTURED DURING INSERTION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24541250 ↗
• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT, DURING A LEFT KNEE ACL RECONSTRUCTION, A BIOSURE HA 6MM X 25MM WAS FRACTURED. THE INSERTION SITED WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION & ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS AND SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED & PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24353949 ↗
• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT DURING A PATELLOFEMORAL LIGAMENT REPAIR PROCEDURE, THE FRONT END OF THE BIOSURE HA ANCHOR BROKE WHILE BEING DRIVEN IN BY SQUEEZING. THE PIECES WERE REMOVED FROM INSIDE THE PATIENT USING TWEEZERS AND SUCTION. THE PROCEDURE WAS RESUMED, AFTER A 10 MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP INSERTED INTO THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345412 ↗
• MalfunctionFeb 12, 2026Fracture

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE HA FRACTURED AS IT WAS DRIVEN INTO THE CHANNEL TO TIGHTEN. THE PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, SO THERE WERE NO VOIDS LEFT. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS AN ANCHOR MATCHING INSTRUMENT AND ALL SITE WAS CLEARED OF ALL DEBRIS PRIOR TO THE INSERTION. PATIENT STATUS IS FINE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321898 ↗
• MalfunctionNov 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE BIOSURE ANCHOR WAS FRACTURED DURING IMPLANTATION. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23483092 ↗
• MalfunctionNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE BIOSURE HA SCREW FRACTURED WHILE BEING INSERTED INTO THE TIBIAL TUNNEL. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23459786 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT, LESS THAN TWO YEARS AFTER A KNEE LIGAMENT RECONSTRUCTION SURGERY, WHICH WAS PERFORMED ON (B)(6) 2023, FRAGMENTS OF THE BIOSURE HA 6MM X 25MM SCREW THAT SHOULD'VE BEEN RESORBED LONG AGO, WERE FOUND IN THE PATIENT DURING A REVISION SURGERY PERFORMED ON (B)(6) 2025. IT IS UNKNOWN IF THE FRAGMENTS WERE REMOVED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Foreign Body Reaction

  MAUDE report 23457334 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, AFTER THE INSERTION SITE WAS PREPARED WITH A 4.5 CANNULATED DRILL BIT, THE BIOSURE SCREW BROKE UPON INSERTION. THE BROKEN PIECES WERE REMOVED USING GILLIES FORCEPS. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE, WHICH WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS HEALTHY AND FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897445 ↗
• MalfunctionAug 4, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, UPON SCREWING INTO THE TIBIA, THE 6X25 BIOSURE SCREW BROKE, IT CRACKED ALONG THE SIDE. ALL BROKEN PIECES WERE REMOVED USING TWEEZERS AND GILLIES. SURGERY WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE, A FOOTPRINT MINI WAS USED TO ANCHOR THE ROOT REPAIR WITHOUT SECONDARY FIXATION OF A SCREW. THE FOOTPRINT DEVICE WAS USED TO ANCHOR THE ULTRALOOP SUTURE INTO THE TIBIA. THERE WAS NO VOID LEFT IN THE PATIENT, AS THE 4.5 FOOTPRINT WAS USED AS A PRIMARY FIXATION. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE REPAIR WAS SUCCESSFUL AND THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709694 ↗
• MalfunctionAug 4, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, UPON SCREWING INTO THE TIBIA, THE 6X25 BIOSURE SCREWS BROKE, IT CRACKED IN HALF. ALL BROKEN PIECES WERE REMOVED USING TWEEZERS AND GILLIES. SURGERY WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE, A FOOTPRINT MINI WAS USED TO ANCHOR THE ROOT REPAIR WITHOUT SECONDARY FIXATION OF A SCREW. THE FOOTPRINT DEVICE WAS USED TO ANCHOR THE ULTRALOOP SUTURE INTO THE TIBIA. THERE WAS NO VOID LEFT IN THE PATIENT, AS THE 4.5 FOOTPRINT WAS USED AS A PRIMARY FIXATION. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE REPAIR WAS SUCCESSFUL AND THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709424 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SURGEON WAS TRYING TO PLACE THE BIOSURE SCREW IN THE WRONG PLACE AND IT BROKE. THE SCREW WAS REMOVED FROM THE PATIENT WITH A GRASPER. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW 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 22552670 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE WITH SUTURE, THE TIP OF THE BIOSURE HELICOIL SCREW BROKE SINCE IT WAS CORTICAL, AND AS THE SURGEON DID NOT USE THE TAP TO INSERT THE SCREW. THE BROKEN TIP OF THE SCREW WAS ONLY CAUGHT IN THE KEY. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748946 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT SHOWED POOR WOUND HEALING AND SLIGHT EXUDATION ONE MONTH AFTER SURGERY FOR A LATERAL LIGAMENT INJURY OF THE RIGHT ANKLE JOINT CAUSED BY A SPRAIN, WHERE TWO BIOSURE SCREWS WERE USED (IMPLANTED ON (B)(6) 2024, ALONG WITH PRP IMPLANTATION AND LIGAMENT REPAIR SURGERY). UPON ADMISSION ON (B)(6) 2024, THE PATIENT UNDERWENT ARTHROSCOPIC EXAMINATION, SYNOVECTOMY, LATERAL TENDON RECONSTRUCTION, JOINT STABILIZATION, AND PRP IMPLANTATION FOR THE LATERAL LIGAMENT INJURY. POSTOPERATIVE DRESSING CHANGES SHOWED GOOD WOUND HEALING WITH NO REDNESS, SWELLING, OR FLUID LEAKAGE. THE PATIENT WAS ADVISED TO FOLLOW THE DOCTOR'S INSTRUCTIONS AND WAS DISCHARGED. ONE MONTH AFTER DISCHARGE, DURING AN OUTPATIENT FOLLOW-UP, POOR WOUND HEALING WITH SLIGHT EXUDATION WAS OBSERVED, BUT THERE WAS NO REDNESS OR SWELLING. RELEVANT EXAMINATIONS WERE COMPLETED, AND SYMPTOMATIC TREATMENTS, INCLUDING INFECTION PREVENTION AND DRESSING CHANGES, WERE PROVIDED. THE SWELLING OF THE AFFECTED LIMB SIGNIFICANTLY SUBSIDED, THE INCISION WAS WELL ALIGNED, AND PERIPHERAL SENSATION AND BLOOD CIRCULATION WERE GOOD. A BACTERIAL CULTURE WAS PERFORMED AND NO BACTERIAL INFECTION WAS DETECTED. THE PATIENT WAS

  Patient problems: Fluid Discharge; Impaired Healing; Swelling/ Edema

  MAUDE report 21668379 ↗
• MalfunctionFeb 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, WHEN IT WAS TRIED TO IMPLANT THE BIOSURE, IT FRACTURED. ALL PIECES WERE REMOVED FROM PATIENT WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES AND SMITH AND NEPHEW A BACK-UP DEVICE WAS USED IN THE SAME ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395403 ↗
• MalfunctionJun 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW BROKE WHILE IT WAS TWISTED IN. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN THE 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 19580633 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL ARTHROSCOPY, A TUNNEL WAS CREATED USING A 7MM DRILL, BASED ON MEASUREMENTS. AFTER SUCCESSFULLY SUTURE SNARING, FLIPPING THE BUTTON, IT WAS OBSERVED THAT THE ENTRANCE OF THE FEMORAL TUNNEL WAS NOT COMPLETELY FILLED WITH TENDONS. SUBSEQUENTLY, THE BIOSURE SCREW WAS USED TO SQUEEZE AND FIX THE FILLING. HOWEVER, THE BIOSURE SCREW THAT WAS DRIVEN CONTINUOUSLY SHATTERED. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143361 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL ARTHROSCOPY, A TUNNEL WAS CREATED USING A 7MM DRILL, BASED ON MEASUREMENTS. AFTER SUCCESSFULLY SUTURE SNARING, FLIPPING THE BUTTON, IT WAS OBSERVED THAT THE ENTRANCE OF THE FEMORAL TUNNEL WAS NOT COMPLETELY FILLED WITH TENDONS. SUBSEQUENTLY, THE BIOSURE SCREW WAS USED TO SQUEEZE AND FIX THE FILLING. HOWEVER, THE BIOSURE SCREW THAT WAS DRIVEN CONTINUOUSLY SHATTERED. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19143359 ↗
• MalfunctionNov 20, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW TIP WAS CRUSHED WHEN THE SURGEON WENT TO INSERT IT. THE PROCEDURE WAS COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18172682 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PATELLOFEMORAL ORTHOPEDIC SURGERY ON (B)(6) 2023 WITH SCREWS FOR INTRAOPERATIVE FIXATION OF THE LIGAMENTS INCLUDING BIOSURE SCREW; THERE WAS SECRETION FROM THE MEDIAL KNEE WOUND 4 WEEKS POSTOPERATIVELY, AND THE WOUND DID NOT IMPROVE SIGNIFICANTLY AFTER DRESSING CHANGES AT THE LOCAL HOSPITAL. ON (B)(6) THE PATIENT UNDERWENT WOUND DEBRIDEMENT WITH VSD DRAINAGE, AND ANTI-INFECTION TREATMENT WAS ALSO GIVEN, AND THE WOUND IS NOW HEALING WELL. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fluid Discharge

  MAUDE report 17777657 ↗
• MalfunctionAug 28, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE SCREW BROKE DURING IMPLANTATION. ALL THE BROKEN PIECES WERE REMOVED USING TWEEZERS. 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 17638891 ↗
• MalfunctionMay 23, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE INSERTING THE BIOSURE SCREW IN THE TIBIA, THE SCREW BROKE BY THE MIDDLE. ALL THE BROKEN PIECES WERE SUCCESSFULLY RETRIEVED BY AN ARTERY FORCEPS, CURETTE AND GRASPERS. THE INSERTION SITE WAS PREPARED WITH A 5MM DRILL. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988851 ↗
• InjuryFeb 28, 2023Break; Break

  IT WAS REPORTED THAT DURING A SURGERY, THE TIP OF THE BIOSURE HA SCREW BROKE AND COULD NOT BE SCREWED IN. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING TWEEZERS. 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. CURRENT STATUS OF THE PATIENT IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452385 ↗
• InjuryFeb 27, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE HA SCREW BROKE WHILE IMPLANTATION. THE BROKEN IMPLANT WAS REMOVED FROM THE PATIENT USING TWEEZERS. 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. CURRENT PATIENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16444408 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON (B)(6) 2022, A PATIENT WAS HOSPITALIZED DUE TO A RIGHT FOOT VARUS DEFORMITY. A RIGHT CALCANEUS OSTEOTOMY, ORTHOPEDIC INTERNAL FIXATION, TRANSPOSITION OF THE POSTERIOR CERVICAL TENDON, AND CONTRACTION OF THE LATERAL ANKLE LIGAMENT WERE PERFORMED UNDER GENERAL ANESTHESIA, USING A BIOSURE ANCHOR. ON (B)(6) 2022, DEBRIDEMENT WAS PERFORMED IN THE HOSPITAL BECAUSE OF "POOR WOUND HEALING". THE PATIENT WAS DISCHARGED AFTER HEALING.

  Patient problems: Insufficient Information

  MAUDE report 15806007 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER 2 WEEKS OF A CORRECTION OF LEFT PATELLAR DISLOCATION UNDER GENERAL ANESTHESIA PERFORMED ON (B)(6) 2022, USING BIOSURE, THERE WAS FLUID COMING OUT FROM THE WOUND. THE WOUND HEALED AFTER DEBRIDEMENT PERFORMED ON (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Fluid Discharge

  MAUDE report 15609610 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080358. 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.
• Z-1225-2012 · Feb 6, 2012 · Terminated
  Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue