BIOSURE 72201778Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 03596010611741), received between Nov 17, 2017 and Jan 9, 2026 — classified as 11 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE LAC PROCEDURE, DURING THE INSERTION OF A BIOSURE ANCHOR, THE RESIDENT DOCTOR DID NOT USE THE PROPER TECHNIQUE, APPLIED EXCESSIVE FORCE, AND ENDED UP CAUSING THE SCREW TO BREAK. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023339 ↗
• MalfunctionNov 19, 2025Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, A BIOSURE HA SCREW BROKE IN HALF WHILST SCREWING IN THE TIBIA. THE SPECIALIST FELT A POP HALFWAY SCREWING, PULLED IT OUT AND HALF THE SCREW WAS ON THE DRIVER AND HALF WAS IN THE PATIENT. NOTHING WAS LEFT INSIDE THE PATIENT; THE HALF WAS PULLED OUT WITH A PAIR OF GRASPERS. THE PROCEDURE WAS RESUMED, AFTER A 5-MIN DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. ADDITIONAL ANESTHESIA WAS REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598487 ↗
• MalfunctionOct 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A CL PROCEDURE, IT WAS NOTICED THAT IT WAS NORMAL TO OPEN THE ROAD BUT THE BIORCI HA ANCHOR BROKE WHEN SCREWED IN. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINAL DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS FINE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390793 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY AND LIGAMENT PROCEDURE, A BIOSURE HA 8 MM X 30MM SCREW BROKE WHILE BEING INTRODUCED GUIDED BY THE NITINOL 1.2 WIRE; THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING A KELLY FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY SURGICAL DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23279133 ↗
• MalfunctionOct 2, 2025Break; Device Dislodged or Dislocated; Material Deformation; Break; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, IT WAS DISCOVERED THAT THE BIOSURE SCREW HAD QUALITY ISSUES SUCH AS LOOSENING, SLIPPING, AND BREAKING. THE PROCEDURE WAS RESUMED, USING AN EQUIVALENT S+N BACK UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23199390 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE BIOSURE SCREW GOT BROKEN INSIDE THE PATIENT, IT WAS REMOVED USING TWEEZERS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, USING THE SAME BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901124 ↗
• MalfunctionOct 28, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE HA ANCHOR BROKE. 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 20551521 ↗
• MalfunctionAug 21, 2024Unstable; Unstable

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE BIOSURE HA ANCHOR WAS UNSTABLE AFTER IMPLANTATION AND WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO AN ADDITIONAL BONE HOLE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 20015997 ↗
• MalfunctionNov 27, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW BROKE WHILE USING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209405 ↗
• MalfunctionMay 11, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW PACKET WAS ALREADY OPEN; THE STERILITY OF THE PACKAGE WAS DISTURBED. 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 16916336 ↗
• InjuryDec 7, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL THE BIOSURE BROKE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT BONE QUALITY WAS GOOD. THE BACK UP WAS USED IN THE ORIGINAL BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. THE INSTRUMENT USE TO PREPARE THE INSERTION SITE WAS A DRILL 8MM, TUNNEL SIZE WAS 8MM. THE SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. PATIENT STATUS IS GOOD AND THE SURGEON WAS ULTIMATELY SATISFICED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932069 ↗
• InjuryOct 18, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIOSURE SCREW BROKE WHILE FIXATION. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15623145 ↗
• InjuryJul 19, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE TIP OF THE BIOSURE BROKE INTO PIECES WHEN IT WAS INSERTED INTO THE TUNNEL. 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15054897 ↗
• InjuryApr 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, TWO BIOSURE ANCHORS FRACTURED DURING THE IMPLANTATION. ALL THE PIECES REMOVED BY TWEEZERS. INSTRUMENT USED TO PREPARE THE SITE WAS A BIOSURE HA. TUNNEL SIZE: 9MM. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. NO DELAY WAS REPORTED AND NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13983216 ↗
• InjuryNov 25, 2021Break; Break

  IT WAS REPORTED THAT DURING AN THAT ACL RECONSTRUCTION, THE BIOSURE HA ANCHOR FRACTURE DURING THE IMPLANTATION. ALL PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12876239 ↗
• InjuryNov 25, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE SCREWDRIVER WAS CONTAMINATED WHEN IT FELL ON THE FLOOR, THE DOCTOR TOOK THE BIOSURE HA STILL EVEN HOT AFTER BEING STERILIZED WITHOUT WAITING FOR IT TO COOL AND PLACED IT IN THE SCREWDRIVER, WHEN INSERTING IT INTO THE PATIENT, THE PRODUCT BROKE. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12875728 ↗
• InjuryNov 12, 2021Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, INTERNAL TO PATIENT, THE SCREW BROKE WHILE IT WAS BEING FIXED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805565 ↗
• InjurySep 9, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE SURGEON WAS REMOVING THE BIOSURE TO SEE WHY IT WAS NOT WORKING, AND IT WAS FOUND THAT A PIECE OF THE BIOSURE WAS INSIDE THE PATIENT. THE PIECE WAS LEFT INSIDE THE PATIENT. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 12445035 ↗
• InjuryJul 9, 2021Break; Break

  IT WAS REPORTED THAT DURING ACL PROCEDURE, INSIDE THE PATIENT, THE BIOSURE HA 8 MM X 30MM BROKE WHEN SCREWED-IN. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH THE TWEEZERS. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LES THAN OR EQUAL TO 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12144594 ↗
• InjuryJun 16, 2021Break; Break

  IT WAS REPORTED THAT DURING USE INSTRUMENTS INSIDE PATIENT IN AN ACL RECONSTRUCTION SURGERY, THE SCREW OF THE BIOSURE BROKE WHEN SCREW-IN. ALL THE BROKEN PIECES WERE REMOVED WITH TWEEZERS AND SUCTION. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12010520 ↗
• InjuryMar 2, 2021Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY THE BIOSURE BROKE INTO SEVERAL PIECES WHEN IT WAS INSERTED INTO THE TUNNEL. NO DELAY OR OTHER COMPLICATIONS REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 11397907 ↗
• MalfunctionMar 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE SCREW CRACKED ON THE SIDE AFTER INSERTING THE GRAFT. NO SIGNIFICANT DELAY OR PATIENT INJURIES WERE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. 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 9809276 ↗
• MalfunctionAug 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, THE SCREW BROKE WHILE IMPLANTING. BROKEN PIECES WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8914846 ↗
• MalfunctionMar 20, 2019Break

  IT WAS REPORTED THAT DURING A TREATMENT AT THE INSERTION OF THE SCREW IN THE FEMUR, THE SCREW BROKE INSIDE THE PATIENT, ALL THE PIECES WERE REMOVED WITH TWEEZERS. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8436661 ↗
• 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 8196605 ↗

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