BIOSURE 72201785Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010611819), received between Aug 3, 2017 and Mar 30, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Crack

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, WHEN THE DOCTOR ATTEMPTED TO INSERT A BIOSURE SCREW, IT WENT IN TOO TIGHT AND WAS FORCED UNTIL THE SCREW CRACKED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24722960 ↗
• MalfunctionMar 18, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE HELICOIL ANCHOR BEGAN TO ROTATE AND WOULD NOT STAY IN THE BONE WHEN INSERTING THE SCREW INTO THE PATIENT'S FEMUR, AND WHEN IT WAS REMOVED WITH TWEEZERS, IT WAS NOTICED THAT THE ANCHOR HAD BROKEN. NO HARM WAS REPORTED TO THE PATIENT. 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 21628071 ↗
• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING THE ARTHROSCOPY + LIGAMENT PROCEDURE, WHEN THE BIOSURE SCREW WAS BEING PLACED IN THE FEMUR, IT BROKE, MAKING IT NECESSARY TO USE ANOTHER ONE. THE FRAGMENTS WERE COMPLETELY REMOVED FROM THE JOINT. THE FRAGMENTS WERE REMOVED WITH A SCREWDRIVER AND KELLY FORCEPS. 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 21318142 ↗
• MalfunctionNov 14, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE THREAD ON THE BIOSURE HA SCREW WAS INCOMPLETE AND THERE WERE DEFECTS IN THE THREAD PREVENT FIXATION. THE ANCHOR WAS REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY 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 20684031 ↗
• MalfunctionOct 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE HA ANCHOR BROKE. THE BROKEN ANCHOR WAS REMOVED FORM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY 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 20507920 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE BIOSURE ANCHOR BROKE OFF, THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING TWEEZERS. 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 19144331 ↗
• MalfunctionFeb 5, 2024Crack; Crack

  IT WAS REPORTED THAT DURING A ACL AND MCL PROCEDURE, THE BIOSURE HA ANCHOR CRACKED WHEN IT WAS BEING TIGHTENED INTO THE BONE TUNNEL. THERE WERE NO FRAGMENTS LEFT IN THE PATIENT. 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 18639893 ↗
• MalfunctionAug 7, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE BIOSURE HA SCREW BROKE WHILE IT WAS SCREWED IN. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17474500 ↗
• InjuryMar 20, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE TIP OF THE BIOSURE SCREW BROKE OFF. THE BROKEN PIECE WAS 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 16579385 ↗
• InjuryFeb 16, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE BIOSURE SCREW BROKE OFF WHILE IT WAS TWISTED IN. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT CURRENT STATUS IS HEALTHY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390466 ↗
• InjuryDec 23, 2020Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE BIOSURE SCREW BROKE AT THE TIP WHILE IT WAS BEING INSERTED INTO THE TUNNEL. ALL PIECES WERE REMOVED WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER 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 11066423 ↗
• MalfunctionMar 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE SCREW WAS FOUND THREAD CROOKED. HOWEVER, THERE WAS NO BREAKAGE INTO THE PATIENT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THE DEVICE WAS DEFORMED AND IT WAS MISSING PIECES AND WAS ACTUALLY USED INSIDE THE PATIENT WHICH MAKES IT A REPORTABLE EVENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9803953 ↗
• MalfunctionJul 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE SCREW TIP BROKE WHILE BEING INSERTED INTO THE TIBIAL TUNNEL. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT'S ANATOMY BY USING AN ARTERY. A BACK-UP DEVICE WAS USED, IN THE SAME BONE HOLE, TO COMPLETE THE PROCEDURE. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8787025 ↗
• MalfunctionJul 2, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT (RIGHT KNEE), THE THREAD OF THE SCREW BROKE DURING THE IMPLANTATION, THE PIECES WERE REMOVED USING TWEEZERS. THERE WAS A SURGICAL DELAY GREATER THAN 30 MINUTES. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8756125 ↗
• MalfunctionApr 20, 2018Break; Device Displays Incorrect Message

  IT WAS REPORTED THAT DURING IMPLANTATION OF THE SCREW, THE BIOSURE SCREW HAS BROKEN WITH NO OBVIOUS CAUSE AND WITHOUT TECHNICAL ERROR. NO PATIENT INJURIES OR DELAY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7449056 ↗
• MalfunctionAug 3, 2017Break

  IT WAS REPORTED THAT THE HEAD OF ANCHOR WAS BROKEN DURING THE IMPLANTATION IN A CRUCIATE LIGAMENT RECONSTRUCTION. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6764761 ↗

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