BIOSURE 72201782Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 03596010611789), received between Aug 22, 2017 and Jun 20, 2026 — classified as 34 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Break” (70 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 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2026Fracture

  IT WAS REPORTED THAT DURING A MEDIAL COLLATERAL LIGAMENT (MCL) RECONSTRUCTION SURGERY, THE HEAD OF A BIOSURE HA 9 MM X 30 MM ANCHOR FRACTURED. THE PROCEDURE WAS RESUMED, AFTER LESS THAN OR EQUAL TO 30MINS, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25570276 ↗
• MalfunctionMay 5, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE ANCHOR WAS FOUND SLIPPED AND COULD NOT SCREW-IN, IT KEPT TWISTING AND THEN THE ANCHOR BREAK. IT WAS REMOVED FROM THE PATIENT. THE SURGERY WAS COMPLETED USING AN EQUIVALENT S&N BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25089338 ↗
• MalfunctionMay 3, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, THE BIOSURE ANCHOR HAD BROKEN INTO PIECES DURING SCREWING IN PATIENT, THE RESIDUE WAS REMOVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25064410 ↗
• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC ACL RECONSTRUCTION, THE BIOSURE SCREW GOT BROKE WHILE INSERTING INTO THE TIBIAL TUNNEL. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING FORCEPS AND SUCTION. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING AN EQUIVALENT S&N BACK-UP DEVICE IN THE ORIGINAL BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058867 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT DURING THE ACL PROCEDURE, WHILE FIXING THE TIBIA WITH THE BIOSURE SCREW, THE TIP OF THE SCREW BROKE, THE SCREW SANK INTO THE KEY AND BROKE. THE PIECES WERE COMPLETELY REMOVED .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 24788701 ↗
• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED THAT, DURING A KNEE ACL , WHILE INSERTING THE BIOSURE SCREW INTO THE TIBIA, THE SCREW THREADS GOT DAMAGED AND THE SCREW BROKE INTO TWO PIECES. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747818 ↗
• MalfunctionMar 24, 2026Material Fragmentation

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, WHEN FIXATING THE TIBIAL END AND TRIED TO IMPLANT ONE (1) BIOSURE ANCHOR IT CRACKED. A 9MM TIBIAL DRILL WAS USED TO MAKE THE BONE HOLE. THE BONE CHANNEL WAS THOROUGHLY CLEANED AND SMOOTHED. THERE WERE FRAGMENTATION OF PIECES AND WERE REMOVED WITH TWEEZERS. 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 24674205 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL, THE BIOSURE SCREW BROKE WHILE BEING INSERTED. ALL THE PARTS WERE REMOVED FROM THE PATIENT WITH GRASPING TONGS. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT SN BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED HOLE. THE INSTRUMENT FOR THE INSERTION SITE WAS A 9MM DRILL. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. THE STATUS OF THE PATIENT IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435087 ↗
• MalfunctionNov 12, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE TIP OF THE BIOSURE HA 9MM X 30MM FRACTURED. 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 23539238 ↗
• MalfunctionSep 14, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, IT WAS NOTICED THAT A BIOSURE SCREW GOT BROKEN WHEN IT WAS ABOUT TO BE COMPLETELY ENGAGED WITH THE BONE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING SUCTION AND A NIBBLER. THE INSERTION SITE WAS PREPARED WITH A 8 MM CANNULATE DRILL, FOLLOWED BY BIOSURE DRIVER FOR SCREW INSERTION. THE PROCEDURE WAS COMPLETED WITHOUT A SURGICAL DELAY USING AN SN BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048078 ↗
• MalfunctionSep 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ACL SURGERY, THE TIP OF THE BIOSURE FRACTURED. THE TIP WAS REMOVED BY SUCTION. IT WAS NOTED THAT THE DRILLING TUNNEL MEASURED 9MM AND IT WAS CLEARED OF ALL DEBRIS PRIOR THE INSERTION OF THE ANCHOR. THE PROCEDURE WAS PERFORMED WITH A SN BACK UP DEVICE USED ON THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN PATIENT. THERE WAS NO SIGNIFICANT SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048071 ↗
• MalfunctionAug 28, 2025Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE DOCTOR FOUND THAT THE SCREW OF THE BIOSURE WAS LOOSE WHEN HE TRIED TO IMPLANT IT, AND THE SCREW SLIPPED, IT COULD NOT BE TWISTED INTO THE TARGET POSITION. FURTHERMORE, THE IMPLANT BROKE WHILE THE DEVICE WAS BEING USED INSIDE THE PATIENT; THE BROKEN COMPONENT WAS REMOVED FROM THE PATIENT USING SUCTION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22915844 ↗
• MalfunctionMay 21, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN TIBIAL PART PROCEDURE, THE BIOSURE COULD NOT BE SCREWED IN THE 8.5MM TIBIAL TUNNEL AND BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED HOLE, SO NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22063412 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BIOSURE ANCHOR BROKE, AND THE PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS COMPLETED IN THE ORIGINALLY DRILLED BONE HOLE, AND NO VOID WAS LEFT IN THE PATIENT. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY. THE PATIENT¿S STATUS WAS FINE, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025497 ↗
• MalfunctionApr 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE SURGEON HAD FIRST SCREWED THE BIOSURE SCREW IN, BUT THE TIP OF THE IT BROKE. THE TIP WAS REMOVED BY THE SURGEON USING TWEEZERS. 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 21929319 ↗
• MalfunctionMar 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN ANTERIOR FORK LIGAMENT RECONSTRUCTION, WHEN TRYING TO SCREW THE BIOSURE HA ANCHOR IN A 9 MM TUNNEL, IT BURST AND WAS NOT ABLE TO BE SCREWED IN. THE BROKEN PIECES WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH TWEEZERS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A SURGICAL 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 21670457 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL, THE BIOSURE SCREW BROKE. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN THE ORIGINAL DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463570 ↗
• MalfunctionAug 21, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, WHEN THE GRAFT WAS PLACED INTO THE FEMUR, THE TIP OF THE BIOSURE SCREW BROKE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT WITH SHAVER SUCTION. 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 20021182 ↗
• MalfunctionAug 20, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BIOSURE-HA SCREW BROKE WHEN BEING INSERTED INTO THE PATIENT CORTICAL. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. 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 20003346 ↗
• MalfunctionJul 25, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, AT THE MOMENT THE SURGEON STARTED TO INSERT THE BIOSURE HA 9MM X 30MM SCREW TO ANCHOR THE GRAFT, THERE WAS A NOISE OF SOMETHING BREAKING, AND WHEN THE WRENCH WAS RETURNED BY THE GUIDE WIRE, IT WAS NOTICED THAT THE ANCHOR TIP WAS BROKEN. THE PIECE WAS REMOVED USING ARTHROSCOPIC TONGS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BIOSURE HA 10MM X 30MM BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19832986 ↗
• MalfunctionJul 17, 2024Crack; Device Dislodged or Dislocated; Crack; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING USE THE BIOSURE SCREW WAS LOOSE AND CRACK AFTER THE IMPLANTATION. THERE WAS A BACK UP DEVICE AVAILABLE. IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766905 ↗
• MalfunctionJul 16, 2024Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE BIOSURE HA ANCHOR BROKE WHEN INSERTING. THE PIECES WERE REMOVED USING KELLY TWEEZERS. 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 19757122 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN STARTING TO INSERT THE BIOSURE SCREW, IT DID NOT GROW AND WHEN IT WAS FORCED TO FIX THE SCREW IT BROKE. IT WAS REMOVED WITH A GRASPER. THE PROCEDURE WAS 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 19644469 ↗
• MalfunctionJun 24, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE BIOSURE HA BROKE. 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 19601233 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE ANCHOR BROKE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID WAS LEFT IN THE 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 19377136 ↗

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