BIOSURE 72201781Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 03596010611772), received between Aug 11, 2017 and May 3, 2026 — classified as 23 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (51 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, A BIOSURE ANCHOR BROKE INTO PIECES WHILE BEING SCREWED INTO THE PATIENT. THE RESIDUE WAS REMOVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. ADDITIONAL ANESTHESIA WAS NOT REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25064416 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE FRONT END OF THE BIOSURE HA SCREW BURST WHILE IT WAS BEING INSERTED. THE PROCEDURE WAS RESUMED USING AN EQUIVALENT S+N BACKUP. IT IS UNKNOWN WHETHER ANY DELAY OCCURRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25005810 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, WHILE PREPARING THE TUNNEL WITH ONE (1) BIOSURE TAPERED SCREW THE TAIL END OF THE SCREW BROKE DURING THE IMPLANTATION PROCESS. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACKUP; 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 24851715 ↗
• MalfunctionMar 30, 2026Crack

  IT WAS REPORTED THAT, DURING SURGERY, THE HEAD OF ONE (1) BIOSURE HA ANCHOR WAS CRACKED. THE PROCEDURE WAS RESUMED, USING A COMPETITOR 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 24732278 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHILE FIXING THE GRAFT IN THE FEMUR, THE SURGEON DIDN¿T WANT TO MALLET THE TUNNEL BY ATTACHING THE BIOSURE HA 9MM X 25MM DIRECTLY TO THE TUNNEL AND WITH EXCESSIVE FORCE, DAMAGING THE TIP OF THE SCREW AND IT BROKE. WHEN REMOVING THE SCREW WITH THE DAMAGED TIP, THE SURGEON REMOVED THE GRAFT AND CLEANED IT WITH THE SHAVER BLADE. AN ADDITIONAL BONE HOLE WAS REQUIRED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 24290266 ↗
• MalfunctionNov 13, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PATELLAR LIGAMENT PROCEDURE, WHEN THE GRAFT WAS BEING FIXED TO THE FEMUR WITH A BIOSURE HA 9MM X 25MM SCREW, THE GRAFT DID NOT HOLD. IT WAS NECESSARY TO REMOVE THE SCREW AND THE GRAFT. THE SCREW WAS DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544693 ↗
• MalfunctionOct 14, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, DURING AN ACL, IT WAS NOTICED THAT THE BIOSURE HA SCREW BROKE DURING IMPLANTATION. ACCORDING TO THE PICTURE, THE ANCHOR WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT SN BACK-UP IN THE ORIGINAL DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276030 ↗
• MalfunctionOct 3, 2025Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE BIOSURE ANCHOR WOULD NOT THREAD AND GRASP INSIDE THE PATIENT. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION FOUND THAT THE THREADS OF THE ANCHOR HAVE FRACTURED AND DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23214003 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INCISION SITE OF A PATIENT IN WHICH A BIOSURE SCREW WAS USED, WOULD NOT HEAL. THE PATIENT HAD TIBIAL WOUND DEHISCING AS WELL AS SUPERFICIAL CELLULITIS AND THE SKIN MACERATED AND SOUPY. IT HAD 1 WEEK OF KEFLEX AND THE INCISION CLOSED TWO TIMES. THE CELLULITIS WAS RESOLVED AND THE TISSUE SURROUNDING THE INCISION WAS DEBRIDED. THE SCREW WAS REMOVED FROM THE PATIENT. THE PATIENT WAS STILL HAVING ISSUES HEALING THE INCISION SITE. THE SURGEON WAS NOT SURE IF IT WAS THE SCREW OR IF IT¿S A COMPLICATION WITH THE CLOSING SUTURE.

  Patient problems: Impaired Healing; Wound Dehiscence

  MAUDE report 22627851 ↗
• MalfunctionJul 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY + LIGAMENT PROCEDURE, THE BIOSURE HA 9MM X 25MM SCREW BROKE WHILE BEING IMPLANTED IN THE PATIENT. THE BROKEN ANCHOR WAS REMOVED WITH KEY AND TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO HARM OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588354 ↗
• MalfunctionApr 24, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE BIOSURE HA SCREW FRACTURED WHILE BEING IMPLANTED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905690 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BIOSURE HA SCREW BROKE. BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH HAND INSTRUMENT. 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 21905630 ↗
• MalfunctionFeb 6, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BIOSURE HA SCREW CRUMBLED WHEN AN ATTEMPT WAS MADE TO SCREW IT IN. A BACK-UP DEVICE WAS AVAILABLE, BUT THE PROCEDURE WAS CANCELLED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21319335 ↗
• MalfunctionDec 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE HA SCREW WAS FRACTURED WHILE IT WAS TWIST IN. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20983998 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ACL+MCL+VIDEOARTHROSCOPY PROCEDURE, WHEN THE BIOSURE SCREW WAS PLACED IT EXPANDED BREAKING THE TIP AND NOT PROGRESSING. IT WAS NOT POSSIBLE TO REMOVE OF THE BONE THE TIP OF THE SCREW. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20464282 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY AND ACL WITH SUTURE, THE BIOSURE SCREW BROKE. THE ANCHOR WAS REMOVED FROM THE PATIENT WITH KELLY FORCEPS. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20242170 ↗
• MalfunctionSep 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE + ACL ARTHROSCOPY, WHEN THE SURGEON STARTED TO THREAD IN THE BIOSURE SCREW, PARTICLES STARTED TO COME OUT. THEN THEY MACHINED IT AND IT WORKED. THE SCREW PARTS WERE REMOVED. 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 20231074 ↗
• MalfunctionSep 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A KNEE + ACL ARTHROSCOPY, WHEN THE SURGEON STARTED TO THREAD IN THE BIOSURE SCREW, PARTICLES STARTED TO COME OUT. THEN THEY MACHINED IT AND IT WORKED. THE SCREW PARTS WERE REMOVED. 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 20230792 ↗
• MalfunctionAug 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE ANCHOR FRACTURED WHILE BEING INSERTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY OF 1-30 MIN. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE SO NO VOID WAS LEFT IN THE PATIENT. ALL PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055559 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THE SCREW BIOSURE HA WAS BEING IMPLANTED BY SURGEON, AND IT BROKE OFF. THE BOTTOM OF THE SCREW WAS LEFT IN PATIENT BECAUSE THE SURGEON DETERMINED IT WAS STILL FUNCTIONAL, WHILE TOP PART OF SCREW WAS REMOVED. 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 19917971 ↗
• MalfunctionMay 29, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE SCREW BROKE. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY BONE HOLE. DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19418185 ↗
• MalfunctionMay 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW SLIPPED FROM THE BONE HOLE. THE SCREW WAS REMOVED WITH A SURGICAL TOOL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19345859 ↗
• MalfunctionApr 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING A MENISCUS REPAIR SURGERY, THE BIOSURE SCREW WAS FOUND SLIPPED INSIDE THE PATIENT, IT DID NOT STAY FIXED. THE SCREW WAS REMOVED. 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'S STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19158585 ↗
• MalfunctionFeb 16, 2024Break; Break

  IT WAS REPORTED THAT DURING THE ACL RECONSTRUCTION SURGERY, TIBIAL TUNNEL SIZE 10MM, THE SCREW BROKE WHILE IMPLANTATION. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE, BUT IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721169 ↗
• MalfunctionAug 7, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE HA SCREW BROKE WHILE SCREWING IN. 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, AND NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17471348 ↗

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