BIOSURE 72201776Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 03596010611727), received between Dec 4, 2017 and Jun 15, 2026 — classified as 16 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (27 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 15, 2026Fracture

  IT WAS REPORTED THAT, DURING A TIBIAL FIXATION, THE ANCHOR OF ONE (1) BIOSURE HA WAS FRACTURED UPON SCREWING IN. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25503612 ↗
• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL SURGERY, THE BIOSURE SCREW WAS SCREWED IN ALONG THE GUIDE. THE TAIL OF THE SCREW WAS FRACTURED HALFWAY THROUGH. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING AN EQUIVALENT S&N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356544 ↗
• MalfunctionSep 9, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT, DURING AN ACL ARTHROSCOPIC PROCEDURE, THE TIP OF THE BIOSURE ANCHOR BROKE AND A CRACK APPEARED. THE SCREW WAS REMOVED AND THE DOCTOR WAS ASKED TO OPEN AN ULTRABUTTON, THE ULTRABUTTON WAS PLACED IN THE FEMUR AND THE SAME ANCHOR WAS REUSED IN THE TIBIA, THEREFORE SURGERY WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23005891 ↗
• MalfunctionSep 5, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LCA PROCEDURE, THE TUNNEL WAS MADE , AND THE DOCTOR TRIED TO PLACE THE BIOSURE HA 8MM X 25MM AND THE TIP BROKE WHEN IT CAME INTO CONTACT WITH THE PATIENT'S BONE. IT WAS REMOVED WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY 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 22985136 ↗
• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, AFTER PREPARING THE INSERTION SITE WITH A TAP AND CLEARING THE INSERTION SITE OF ALL DEBRIS, THE BIOSURE ANCHOR BROKE. THE DEVICE'S BROKEN PIECES WERE REMOVED USING TWEEZERS. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE, 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 FINE AND THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851012 ↗
• MalfunctionApr 29, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE THE BIOSURE SCREW WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE AVAILABLE. IT IS UNKNOWN IF THERE WAS A DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21930598 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT DURING SURGICAL IMPLANTATION, THE FRONT END OF THE BIOSURE ANCHOR WAS PUNCTURED. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACKUP DEVICE; HOWEVER, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926029 ↗
• MalfunctionSep 18, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ACL REVISION, WHEN FIXING THE PATELLAR GRAFT, ONE UNIT (1) OF THE BIOSURE SCREW BROKE AT THE END, THEN ANOTHER UNIT (1) OF THE BIOSURE SCREW BROKE IN HALF. THE SCREW WAS PARTIALLY REMOVED SINCE PART OF THE DEVICE WAS FIXING THE GRAFT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF 10 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20252014 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN INSERTING THE BIOSURE HELICOIL SCREW INTO THE TIBIAL TUNNEL, IT BROKE WITHOUT EXERTING FORCE, THE DEVICE WAS REMOVED IN ITS ENTIRETY. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. THE PATIENT IS STABLE, NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19492254 ↗
• MalfunctionMay 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW THREADS SLIPPED OUT OF THE BONE HOLE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED 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 19402169 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS REPORTED THAT THE BIOSURE HA SCREW SHAFT GOT BROKEN WHILE SCREWING INTO THE BONE, BROKEN PIECES WERE REMOVED FROM THE BONE WITH THE HELP OF A GRASPER. 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 18767541 ↗
• MalfunctionNov 21, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE BIOSURE SCREW CRACKED. THE ORIGINAL DRILLED BONE HOLE WAS USED AND NO PIECE FELL INTO THE PATIENT'S WOUND. 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 18184704 ↗
• MalfunctionOct 23, 2023Crack; Crack

  IT WAS REPORTED THAT THE BIOSURE SCREW HAD THE DISTAL END FRACTURED AWAY FROM THE PROXIMAL PORTION OF THE DEVICE AND THERE ARE SEVERAL FRACTURED THREADS. THERE WAS BIOLOGICAL DEBRIS ON THE DEVICE. THE DEFICIENCY WAS OBSERVED WHILE PERFORMING THE INVESTIGATION FOR THE DEVICE AND NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993370 ↗
• MalfunctionJul 6, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION FOR AN ARTHROSCOPY, THE BIOSURE HAD AN AIR LEAKAGE IN THE INNER PACKAGING WHEN IT WAS OPENED BEFORE SURGERY. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17275446 ↗
• MalfunctionJun 10, 2023Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION SURGERY, THE BIOSURE HA 8MM X 25MM SCREW BROKE WHILE IMPLANTATION. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MIN USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102186 ↗
• InjuryDec 21, 2022Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BIOSURE SCREW WAS CRACKED. THE SURGERY WAS RESUMED WITH A BACK-UP DEVICE, BUT IT IS UNKNOWN WHETHER IT CAUSED OR NOT A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024216 ↗
• InjuryNov 27, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY THE BIOSURE SCREW BROKE. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE ORIGINAL DRILL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15867171 ↗
• InjurySep 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING A CRUCIATE LIGAMENT SURGERY, TWO (2) BIOSURE HA INTERFERENCE SCREWS BROKE WHILE SCREWING, THE BONE TUNNEL WAS 7MM. NO SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT STATUS OF THE PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406373 ↗
• InjurySep 5, 2022Break; Break

  IT WAS REPORTED THAT DURING A ACL RECONSTRUCTION SURGERY THE BIOSURE HA SCREW BROKE WHILE IT WAS SCREWED IN. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT BY TWEEZERS. THE PROCEDURE WAS FINISHED USING A BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15358013 ↗
• InjuryAug 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, IT WAS NOTICED THAT THE BIOSURE SCREW WAS WARPED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. AS PER INVESTIGATION RESULTS, THE DISTAL END OF THE DEVICE IS FRACTURED AWAY AND THE INTERIOR HAS DEBRIS AND BLACK MARKINGS AT THE PROXIMAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15316432 ↗
• InjuryAug 19, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE SCREW BROKE AND COULDN'T BE USED. ALL THE PIECES WERE REMOVED FROM THE PATIENT BY TWEEZERS. SURGERY WAS RESUMED 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 15259303 ↗
• InjuryJul 7, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE BIOSURE SCREW FRACTURED WHEN IT WAS BEING SCREWED IN. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES USING A BACK-UP DEVICE IN THE ORIGINAL BONE HOLE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING FORCEPS AND SUCTION. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14950259 ↗
• InjuryJun 10, 2022Break; Device Dislodged or Dislocated; Material Deformation; Break; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC PROCEDURE, THE BIOSURE SCREW HAD WEAR ON ITS CUTTERS, CAUSING THAT THE DEVICE COULD NOT FIX IN THE BONE. THE SURGEON FOLLOWED THE TECHNIQUE CORRECTLY DRILLING THE BONE CHANNEL, BUT EVEN SO THE SCREW LOST ITS CUTTERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY AS A RESULT OF THE REPORTED EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14661051 ↗
• InjuryMay 14, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY RECONSTRUCTION SURGERY, THE BIOSURE SCREW WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PER PRELIMINARY RESULTS OF INVESTIGATION IT WAS CONFIRMED THE DISTAL END OF THE SCREW WAS FRACTURED, AND THERE WAS DEBRIS ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14403424 ↗
• InjuryMay 9, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN NUMBER OF ACL PROCEDURES, AN UNKNOWN NUMBER OF BIOSURE SCREW CUT THE TENDON AND ALSO THE SCREWS BROKE WHEN SENDING THEM INTO THE TUNNEL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BIORCI SCREW. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336862 ↗

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