BIOSURE 72201774Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03596010611703), received between Sep 14, 2017 and Aug 18, 2025 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT, IN THE FINAL STAGE OF AN ARTHROSCOPIC POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY DURING THE IMPLANTATION OF TWO (2) UNITS OF THE BIOSURE HA SCREWS, THEY WERE BURST AND FAILED, FORCING CONTINUOUS CHANGES IN THE TUNNEL COMPRESSION POSITION. THE PIECES WERE NOT REMOVED, THEY WERE LEFT SECURED IN THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22835136 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT DURING A PCL RECONSTRUCTION SURGERY, THE FRONT END OF THE BIOSURE SCREW WAS BROKEN DURING IMPLANTATION AND COULD NOT BE USED. THE BROKEN PIECES WERE REMOVES USING TWEEZERS. THE INSERTION SITE CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE AND NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612601 ↗
• MalfunctionOct 21, 2024Break; Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT SURGERY, THE BIOSURE HA ANCHOR CRACKED AND THE TIP BROKE WHILE BEING INSERTED. 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 20501261 ↗
• MalfunctionApr 23, 2024Break; Break

  IT WAS REPORTED THAT DURING A ARTHROSCOPY+PATELLAR REALIGNMENT, THE 7MMX30MM BIOSURE SCREW BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A 7MMX25MM BIOSURE AS BACK-UP DEVICE. THE BROKEN PIECES WERE REMOVED FROM PATIENT. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19161180 ↗
• MalfunctionAug 28, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE SCREW BROKE WHILE IT WAS BEING SCREWED IN. 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 17638869 ↗
• MalfunctionJul 5, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING SET-UP, A BIOSURE HA ´S INNER PACKAGING BAG HAD ITS AIR LEAKED; WHICH COMPROMISED THE STERILE BARRIER. THERE WAS A BACK-UP DEVICE AVAILABLE AND NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260363 ↗
• MalfunctionApr 22, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE ANCHOR BROKE WHILE SCREWING. ALL THE PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE STATUS OF THE PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792746 ↗
• MalfunctionApr 22, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE SCREW BROKE WHILE IT WAS BEING SCREWED. ALL THE PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE STATUS OF THE PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792745 ↗
• InjuryMar 27, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE BIOSURE BROKE DURING EMPLOYMENT. 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 16619999 ↗
• InjuryJan 10, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE SCREW 'BIOSURE HA' WAS THROUGH THE BONE TUNNEL, THE SCREW BROKE. ALL PIECES WERE REMOVED FROM THE PATIENT BY FORCEPS. THE PROCEDURE WAS COMPLETED WITH AN S+N BACKUP DEVICE. NO DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT STATUS OF THE PATIENT IS GOOD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206532 ↗
• InjuryJul 8, 2021Break; Break

  IT WAS REPORTED THAT DURING ACL PROCEDURE, INSIDE THE PATIENT, THE BIOSURE HA 7MM X 30MM WAS BROKEN. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN OR EQUAL TO 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136758 ↗
• InjuryJul 1, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN USING THE SCREW, IT BROKE INSIDE THE CORTICOL. KELLY CLAMP WAS USED TO REMOVE IT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10221479 ↗
• MalfunctionNov 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE BIOSURE ANCHOR BROKE. FRAGMENTS WERE COMPLETELY RETRIEVED FROM WITHIN THE PATIENT. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED. 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 9302894 ↗
• MalfunctionOct 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE POINT OF THE PRODUCT, BROKE. ALL PIECES WERE REMOVED FROM PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9150817 ↗
• MalfunctionJul 22, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT AT THE BEGINNING OF AN ACL SURGERY, WHEN STARTING THE TUNNEL FIXING PROCEDURE THE DEVICE BROKE INSIDE THE PATIENT; ALL PIECES WERE REMOVED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8814175 ↗
• MalfunctionApr 29, 2019Break

  IT WAS REPORTED THAT THE SCREW WAS BROKEN. UNKNOWN IF THERE WAS A DELAY, IF BACKUP WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8560276 ↗
• MalfunctionApr 25, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE SCREW BROKE OFF. IT'S TIP WAS DAMAGED. IS UNKNOWN IF A DELAY HAPPENED AND IF A BACKUP DEVICE WAS AVAILABLE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8548972 ↗
• MalfunctionJan 4, 2019Break; Material Puncture/Hole

  IT WAS REPORTED THAT, DURING A PROSTHESIS IMPLANT, THE BIOSURE HA SCREW BROKE WHILE IMPLANTED. ALL FRAGMENTS WERE REMOVED. A BACK-UP SCREW WAS AVAILABLE AND USED IN THE SAME BONE HOLE IN ORDER TO FINISH THE PROCEDURE. NEITHER SIGNIFICANT DELAY NOR PATIENT INJURIES WERE STATED. AS FOR SURGICAL PREPARATION, THE PATIENT HAD AN AVERAGE BONE QUALITY. AN AUTOGENOUS GRAFT WAS USED. BOTH TUNNEL SIZE AND TIBIAL DRILLER HAD 7 MM. ALL PREPARATION INSTRUMENTS WERE S&N PRODUCTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8217245 ↗
• MalfunctionDec 26, 2018Break

  IT WAS REPORTED THAT DURING THE SURGERY BIOSURE HA SCREW BROKE . NO PATIENT INJURY REPORTED. BACK UP DEVICE WAS AVAILABLE. BROKEN PIECES WERE REMOVED FROM THE PATIENT'S ANATOMY

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8196654 ↗
• MalfunctionDec 12, 2018Break

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN TRIED TO INSERT THE SCREW AT THE TIBIAL HEAD, THE SCREW BROKE. NO PATIENT INJURY OR SIGNIFICANT DELAY WERE REPORTED. BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8157697 ↗
• InjurySep 14, 2017Scratched Material

  IT WAS REPORTED THE TIBIAL BAND WAS FOUND TO BE LACERATED BY THE SCREW. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6866613 ↗

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