BIOSURE 72201772Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 03596010611680), received between Oct 6, 2017 and Mar 11, 2026 — classified as 20 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Crack

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION PROCEDURE, THE BIOSURE ANCHOR HAD A CRACK IN ITS ANTERIOR SECTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE, THERE WAS NO VOID LEFT. NO FURTHER COMPLICATIONS WERE REPORTED, PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24571642 ↗
• MalfunctionJan 5, 2026Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE TIP OF A BIOSURE HA SCREW FELL AWAY WHEN SCREWING IT INTO THE TIBIA, AND THE DRIVER FORGED THROUGH THE DISTAL TIP. THE TIP WAS REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS RESUMED WITH A 2 MINUTE SURGICAL DELAY USING AN EQUIVALENT S+N BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. ADDITIONAL ANESTHESIA WAS REQUIRED DUE TO THE SURGICAL PROLONGATION, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959128 ↗
• MalfunctionJun 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN INSERTING ONE (1) BIOSURE HA 7MM X 25MM FOR THE ALL, THE DOCTOR APPLIES FORCE AND THE TIP OF THE SCREW BROKE. THE BONE QUALITY WAS GOOD. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH THE HELP OF GRASPER FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22155515 ↗
• MalfunctionJun 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A VD LIGAMENT PROCEDURE, THE BIOSURE SCREW BROKE AT THE BEGINNING OF THE TUNNEL AND FRAGMENTED INTO SEVERAL PIECES, WHICH WERE REMOVED USING A GRASPER FORCEPS. THE PROCEDURE WAS COMPLETED USING A SCREW FROM ANOTHER COMPANY. THERE WAS A 2-HOUR SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22121257 ↗
• MalfunctionJun 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A VD LIGAMENT PROCEDURE, A BIOSURE SCREW OPENED AS A BACKUP DEVICE, AND DURING INSERTION INTO THE FEMORAL TUNNEL, IT BROKE HALFWAY THROUGH. IT WAS NOT POSSIBLE TO REMOVE THE SCREW FROM INSIDE THE TUNNEL, AND HALF OF IT REMAINED IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SCREW FROM ANOTHER COMPANY. THERE WAS A 2-HOUR SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22121255 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT, DURING A VD LIGAMENT PROCEDURE, THE BIOSURE SCREW FAILED TO PROGRESS AND IT BROKE. THE PROCEDURE WAS COMPLETED WITH A TITANIUM SCREW FROM ANOTHER COMPANY. THERE WAS A SURGICAL DELAY OF TWO HOURS, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092551 ↗
• MalfunctionMay 27, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING A VD LIGAMENT PROCEDURE, WHEN THE BIOSURE SCREW WAS INSERTED, IT PROGRESSED HALFWAY, IT WAS THEN REMOVED TO CHECK THAT IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A TITANIUM SCREW FROM ANOTHER COMPANY. THERE WAS A SURGICAL DELAY OF TWO HOURS, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092235 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT, DURING A TIBIA FIXATION SURGERY, THE BIOSURE SCREW WAS FRACTURED. ALL THE BROKEN PIECES WERE RETRIEVED FORM THE PATIENT WITH TWEEZERS. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD USED IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543246 ↗
• MalfunctionMar 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY + ACL PROCEDURE, THE TIP OF THE BIOSURE HELICOIL BROKE WHILE BEING PLACED IN THE FEMORAL TUNNEL. IT WAS NOT POSSIBLE TO REMOVE THE BROKEN PART FROM THE PATIENT'S BONE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21533524 ↗
• MalfunctionNov 27, 2024Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING A VD LIGAMENT PROCEDURE, WHEN MAKING THE FEMUR AND TIBIA TUNNELS AND PASSING THE LIGAMENT GRAFT, THE GUIDE WIRE WAS INSERTED TO PLACE THE BIOSURE HA SCREW; HOWEVER, THE SCREW ONLY ADVANCED HALFWAY THROUGH THE TUNNEL AND DID NOT PROGRESS ANY FURTHER. THE SCREW WAS REMOVED FOR INSPECTION, AND A BREAKAGE WAS DETECTED. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797326 ↗
• MalfunctionNov 5, 2024Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, AFTER PLACING IN THE PATIENT A BIOSURE HA 7MM X 25MM (B)(4) AND A BIOSURE HA 6MM X 25MM (B)(4) THEY LOGGED IN THE KEY, THE SCREWS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614239 ↗
• MalfunctionAug 21, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL SURGERY, WHILE SCREWING THE BIOSURE HA ANCHOR INTO THE BONE TUNNEL, THE SCREW BROKE AND IT WAS REMOVED FROM THE PATIENT. 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. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023663 ↗
• MalfunctionAug 13, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BIOSURE-HA SCREW BROKE WHEN TURNED INTO THE TUNNEL. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978733 ↗
• MalfunctionAug 5, 2024Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING A LIGAMENT PROCEDURE, WHILE THE DOCTOR WAS TIGHTENING THE BIOSURE SCREW, IT WAS NOT FIXING IT. ADDITIONALLY, THE DOCTOR APPLIED EXCESSIVE FORCE AND THE SCREW BROKE. ALL PARTS WERE REMOVED FORM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19907736 ↗
• MalfunctionJul 18, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIOSURE HA SCREW WAS BROKEN DURING USE. 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 19774390 ↗
• MalfunctionApr 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, WHEN THE BIOSURE SCREW WAS PLACED THROUGH THE GUIDE WIRE, A SMALL CLEAK AND RESISTANCE WAS IDENTIFIED IN THE PROGRESSION OF THE SCREW; WHEN RETURNING THE SCREW, THE TIP OF THE SCREW WAS FOUND TO BE BROKEN. THE DEVICE WAS REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094145 ↗
• MalfunctionMar 26, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE + ACL FLEXOR ARTHROSCOPY, THE BIOSURE HELICOIL ANCHOR BROKE OFF WHEN PLACING THE SCREW INTO THE BONE TUNNEL. THE FRAGMENTS WERE REMOVED WITH THE AID OF KELLY TONGS. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984214 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT DURING A BICEPS TENDON RECONSTRUCTION, THE THREAD OF THE BIOSURE HA 7MM*25MM SCREW WAS FRAGMENTED AFTER SCREWING IN 5MM. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE, NO VOID LEFT IN PATIENT. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960261 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, DURING SCREWING IN TIBIA, THE SCREW OF THE BIOSURE GOT BROKEN. ALL THE BROKEN PIECES WERE REMOVED USING GRASPERS. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607744 ↗
• MalfunctionJan 18, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE BIOSURE BROKE DURING EMPLOYMENT. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH SURGICAL INSTRUMENTS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY BONE HOLE, NO VOIDS WERE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540477 ↗
• MalfunctionDec 22, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE TIP OF THE BIOSURE SCREW BROKE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINAL DRILLED BONE HOLE. NO VOID LEFT IN THE PATIENT. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT BY SUCTION. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387774 ↗
• MalfunctionNov 3, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE HA SCREW BROKE WHILE IT WAS BEING IMPLANTED. ALL THE PIECES WERE REMOVED FROM INSIDE THE PATIENT USING TWEEZERS. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE. THERE WAS NO VOID LEFT INSIDE THE PATIENT. A 7MM DRILL WAS USED TO PREPARE THE INSERTION SITE, AND IT WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18067948 ↗
• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, WHEN INSERTING THE BIOSURE SCREW IN THE FEMORAL TUNNEL GREATER RESISTANCE WAS FOUND HALFWAY THROUGH INSERTION. FORCING THE SCREW IN AN ATTEMPT TO TIGHTEN, THE SCREW BROKE IN HALF. THE BROKEN SCREW WAS REMOVED USING A GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT 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 17999484 ↗
• MalfunctionOct 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIOSURE SCREW WAS EASILY PULLED OUT. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873051 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RECONSTRUCTION OF THE MEDIAL PATELLOFEMORAL LIGAMENT IN WHICH A BIOSURE ANCHOR WAS USED, ON THE (B)(6) 2023 THE PATIENT´S WOUND STARTED TO DISCHARGE OOZING AND POOR HEALING WAS NOTED. ON THE (B)(6) 2023 A DEBRIDEMENT PROCEDURE WAS PERFORMED, AND THE HEALING IMPROVED AFTER THE PROCEDURE. THE IMPLANT REMAINED IN THE PATIENT AFTER THE DEBRIDEMENT. THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Fluid Discharge; Impaired Healing

  MAUDE report 17749016 ↗

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