BIOSURE 72201768Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 03596010611642), received between Nov 1, 2017 and Jun 8, 2026 — classified as 12 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (28 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall 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.

Recalls naming this device

1. Nov 24, 2025Open, Classified

   Removal of affected lot of screws due to labeling error.

   Z-0957-2026 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Break

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION, ONE (1) BIOSURE ANCHOR BROKE. THE PROCEDURE WAS PERFORMED USING AN EQUIVALENT S+N BACK-UP. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425966 ↗
• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE BIOSURE HA SCREW ANCHOR BROKE AT THE VERY BEGINNING OF THE BONE TUNNEL WHILE INSERTING IT TO ANCHOR THE LIGAMENT FOR ANTERIOR REINFORCEMENT. THE FRAGMENT WAS REMOVED USING ARTHROSCOPIC FORCEPS AND KELLY FORCEPS. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25145680 ↗
• MalfunctionMar 15, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, A BIOSURE SCREW BROKE DURING GRAFT FIXATION. THE SCREW WAS REMOVED FROM THE PATIENT, LEAVING NOTHING INSIDE. THE PROCEDURE WAS RESUMED, AFTER A 30-MINUTE DELAY, AS THE SURGEON HAD TO PERFORM A SECOND PASS FOR SCREW FIXATION, USING AN EQUIVALENT S+N BACK-UP. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601482 ↗
• MalfunctionNov 14, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT DURING A LIGAMENTOPLASTY, WHEN ATTEMPTED TO INSERT AND SCREW THE BIOSURE SCREW INTO THE PATIENT'S KNEE. THE SCREW BROKE INSIDE THE PATIENT. ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. UPON INSPECTION, IT WAS FOUND THAT THIS SCREW DID NOT MATCH THE SCREWS NORMALLY USED (DIFFERENT COMPOSITION). THE SURGERY WAS COMPLETED USING AN EQUIVALENT SN 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 23556652 ↗
• MalfunctionNov 3, 2025Break; Packaging Problem; Wrong Label; Break; Packaging Problem; Wrong Label

  IT WAS REPORTED THAT THE BOX OF A BIOSURE 6MM X 20MM HAD PACKAGED A BIOSURE SCREW 5 X 20MM INSTEAD AND WAS FOUND DURING THE KNEE MEDIAL PATELLA FEMORAL LIGAMENT RECONSTRUCTION, AND ADDITIONALLY, IT BROKE WHEN BEING INSERTED INTO THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A 2-MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23460400 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE WITH MENISCAL SUTURE, THE BIOSURE HA SCREW BROKE AT THE TIME OF FIXATION AS IT WAS RESECTED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE WITH NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21464726 ↗
• MalfunctionFeb 4, 2025Break; Break

  IT WAS REPORTED THAT DURING THE ACL PROCEDURE, THE BIOSURE HA SCREW BROKE DURING FIXATION. THE FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT. 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 21303609 ↗
• MalfunctionOct 14, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ACL SURGERY, THE BIOSURE SCREW BROKE WHILE FIXING THE GRAFT. THE BROKEN PIECES WERE COMPLETELY REMOVED FROM THE PATIENT. NO SURGICAL DELAY WAS REPORTED; HOWEVER, IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20444077 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE BIOSURE SCREW GOT BROKEN WHILE SCREWING INTO THE BONE. ALL THE BROKEN PIECES WERE REMOVED FROM THE BONE WITH THE HELP OF TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 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 20257143 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW DECRUSTED (CHIPPED OFF) WHEN INSERTING IT INTO THE BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. IT UNKNOWN IF THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952193 ↗
• MalfunctionFeb 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE BIOSURE TIP BROKE AFTER BEING INSERTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753304 ↗
• MalfunctionDec 27, 2023Break; Break

  IT WAS REPORTED THAT A PROCEDURE, THE SURGEON DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND PROCEEDED TO USE THE MALE WITHOUT CLEANING THE ROUTE IN THE SOFT PARTS; WHICH RESULTED IN THE BIOSURE HA MAKING A FALSE TRAJECTORY AND ENDED UP BREAKING. THE BROKEN PIECES WERE TOTALLY REMOVED. SURGERY CONTINUED WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18405727 ↗
• MalfunctionDec 26, 2023Break; Break

  IT WAS REPORTED THAT DURING A MEDIAL COLLATERAL LIGAMENT PROCEDURE, THE TIP OF THE BIOSURE SCREW BROKE AFTER THE DOCTOR APPLIED TOO MUCH FORCE. THE FRAGMENT WAS REMOVED WITH THE HELP OF TWEEZERS. 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 18394926 ↗
• MalfunctionDec 6, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT DURING SET UP, THE INNER PACKING OF THE BIOSURE HA HAD AN AIR LEAKAGE. THERE WAS A SMITH AND NEPHEW BACK-UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278240 ↗
• MalfunctionSep 29, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN THE BIOSURE SCREW SEALED PACKAGE WAS OPENED, NO SCREWS WERE FOUND INSIDE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE, A DELAY GREATER THAN 30 MINUTES WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843904 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL; HOWEVER UNKNOWN IF INTERNAL OR EXTERNAL TO THE PATIENT; A BIOSURE SCREW BROKE. SURGERY RESUMED WITH A BACK-UP DEVICE; HOWEVER IT IS UNKNOWN IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17113389 ↗
• MalfunctionJun 12, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI SCREW BROKE. IT IS UNKNOWN IF THERE WAS ANY DELAY, HOWEVER, A BACK-UP DEVICE WAS AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107865 ↗
• InjuryFeb 27, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, TWO BIOSURE SCREWS BROKE WHILE IMPLANTATION. ALL THE PIECES WERE REMOVED FROM THE PATIENT BY TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 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 16444471 ↗
• InjuryNov 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ANKLE RECONSTRUCTION, THE BIOSURE SCREW BROKE INSIDE THE PATIENT. THE FRACTURE PIECES WERE REMOVED FROM THE PATIENT BY TWEEZERS. THE SURGERY WAS RESUMED AFTER 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 15817609 ↗
• InjuryNov 11, 2022Break; Break

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF ANKLE, THE SCREW BROKE. ALL FRACTURED PIECES WERE REMOVED FROM THE PATIENT BY TWEEZERS. THE ORIGINALLY DRILLED BONE HOLE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. PATIENT STATUS IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785060 ↗
• InjuryOct 20, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE TIP OF THE 6X20MM BIOSURE HA SCREW BROKE WHEN THE DOCTOR WAS PUTTING IT ON THE PATIENT. IT WAS COMPLETELY REMOVED USING ANOTHER SCREW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15643342 ↗
• InjurySep 2, 2022Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION OPERATION, THE BIOSURE SCREW BROKE. THE PIECES WERE RETRIEVED BY TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 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 15352319 ↗
• InjuryAug 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, A BIOSURE SCREW BROKE IN HALF AND PART OF IT WAS LEFT INSIDE THE PATIENT. PROCEDURE GOT FINISHED WITHOUT ANY DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 15215138 ↗
• InjuryJul 11, 2022Break; Break

  IT WAS REPORTED THAT DURING A ACL RECONSTRUCTION SURGERY, THE BIOSURE BROKE. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT BY TWEEZERS. PATIENT BONE QUALITY WAS NORMAL. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. THE BACK UP DEVICE WAS USED IN THE ORIGINAL BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. AN AWL WAS USED TO PREPARE THE INSERTION SITE, THE INSTRUMENT SIZE WAS 6MM AND THE TUNNEL SIZE WAS 6MM. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS. PATIENT STATUS IS GOOD AND THE SURGEON WAS ULTIMATELY SATISFICED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982204 ↗
• InjuryJul 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE BIOSURE SCREW BROKE. SURGERY WAS RESUMED WITH A BACK UP DEVICE INSTEAD, BUT IT IS UNKNOWN WHETHER IT CAUSED OR NOT A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14911471 ↗

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-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