BIOSURE 72201775Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010611710), received between Aug 31, 2021 and Apr 9, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT DURING AN ACL KNEE ARTHROSCOPY, THE BIOSURE HA SCREW BROKE WHILE BEING SECURED INTO THE BONE AND ATTACHING THE GRAFT. THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING A KEY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831376 ↗
• MalfunctionApr 24, 2025Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE ANCHOR SLIP, CAUSING DAMAGED ON THE IMPLANT. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY BONE HOLE. 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 21905546 ↗
• MalfunctionMar 17, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIOSURE-HA WAS NOT HOLDING WHEN IT WAS BEING INSERTED AND THE TIP WAS BROKEN. THE PIECE WAS 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 21627798 ↗
• MalfunctionJan 31, 2024Break; Break

  IT WAS REPORTED THAT DURING A LCA PROCEDURE, THE BIOSURE HA BROKE AT THE TIME OF FIXING, THE BROKEN PIECES WERE REMOVED USING GRASPERS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18614743 ↗
• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY, A THREAD OF THE BIOSURE HA SHEERED OFF FROM THE SCREW WHEN INSERTING IT. THE DOCTOR DID NOT FEEL THE NEED TO REMOVE THE SCREW AND WAS SATISFIED WITH THE FIXATION. THE SHEARED OFF PIECE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185384 ↗
• MalfunctionApr 24, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE HA BROKE WHILE ATTEMPTING TO FIX THE TENDON TO THE BONE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. THE BACK-UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CURRENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797499 ↗
• InjuryMar 1, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE DOCTOR DRILLED A 8.5MM TUNNEL TO INSERT THE 8.20 MM SCREW OF THE BIOSURE HA 8MM X 20MM AND THE TIP BROKE. THE PIECE WAS REMOVED WITH THE HELP OF THE GRASPER AND SHAVER BLADE. A VOID WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DELAY GREATER THAN 30 MINUTES, USING ANOTHER CORTICAL SCREW TO FIX THE FEMUR. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Rupture

  MAUDE report 16461419 ↗
• InjuryDec 8, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY USING A BIORCI, WHEN PLACING THE SCREW IN THE HOLE, THE MATERIAL INSIDE THE PARENT MATERIAL BROKE AND IT ADHERED TO THE BONE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. BONE QUALITY WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15942254 ↗
• InjuryAug 31, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW BROKE INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. THE BROKEN PIECES WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT WITH TWEEZERS. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12395386 ↗

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