BIOSURE 72204405Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00885554036817), received between Nov 24, 2017 and Mar 30, 2026 — classified as 11 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (24 reports).

1 other recall cover devices cleared under the same FDA submission (K142948); 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE BIOSURE SCREW'S TIP BROKE INTO 3 PIECES WHILE IT WAS BEING INSERTED INTO THE TIBIAL TUNNEL TO SECURE THE GRAFT USING THE BIOSURE SCREWDRIVER. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE; THERE WAS NO VOID LEFT IN THE PATIENT. THE TIBIA TUNNEL WAS FIRST DRILLED USING THE 2.4MM GUIDE WIRE, THE 8MM TIBIA REAMER FROM THE ALC SET WAS USED TO OVER-DRILL THE 2.4MM TUNNEL, A STARTER WAS USED TO PREPARE THE INSERTION SITE BEFORE INSERTING THE SCREW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716267 ↗
• InjuryMar 2, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, A PATIENT IN WHICH A BIOSURE REGENESORB INTERFERENCE SCREW WAS IMPLANTED, DEVELOPED PAIN AFTER A CERTAIN PERIOD OF TIME, AND A PORTION OF THE SCREW BECAME PALPABLE BENEATH THE SKIN. OVER TIME, THE SCREW APPEARED TO GRADUALLY BACK OUT FROM ITS ORIGINAL POSITION. ON (B)(6) 2025, THE PATIENT UNDERWENT AN OPERATION TO REMOVE THE SCREW CRUMBS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Inadequate Osseointegration; Pain; Subcutaneous Nodule

  MAUDE report 24490319 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, IT WAS NOTICED THAT THE SCREW BIOSURE REGENESORB 9 MM X 30 MM BROKE WHILE INSERTING IT AT THE TIBIA TUNNEL AFTER AN 8 MM DIAMETER HAMSTRING GRAFT WAS PREPARED. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT 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 23888802 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BIOSURE SCREW BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640389 ↗
• MalfunctionNov 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY THE BIOSURE REGENESORB SCREW BROKE DURING DEPLOYMENT, WITH THE REMAINING PART OF THE IMPLANT BECOMING STUCK AND FRAGMENTING INTO VERY SMALL PIECES DURING REMOVAL; AN 8 MM TIBIA ENDOSCOPY DRILL WAS USED FOR THE TIBIAL TUNNEL. THE SURGERY WAS COMPLETED USING A BACKUP DEVICE INSTEAD, 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 23621023 ↗
• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BIOSURE SCREW BROKE. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604872 ↗
• MalfunctionMay 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW GOT BROKEN DURING INSERTION INTO BONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. ALL PIECES WERE REMOVED FROM THE PATIENT WITH ARTERY AND MOSQUITO INSTRUMENT. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE SO NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084672 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SCREW BIOSURE ANCHOR BROKE WHILE PUTTING INTO THE BONE. 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 problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067005 ↗
• MalfunctionFeb 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, DESPITE USING THE BIOSURE TAP SAME SIZE AS THE SCREW, PROBLEMS WERE EXPERIENCED WITH TWO (2) REGENESORB BIOSURE INTERFERENCE SCREW. FOR THE FIRST TRIAL OF THE FIXATION IN THE TIBIAL TUNNEL SIZE 9 WITHOUT USING THE BIOSURE TAP, THE SCREW BROKE. AFTER USING THE BIOSURE TAP OF THE SAME SIZE OF THE SCREW IN THE SAME TUNNEL, THE SECOND TRIAL SCREW ALSO BROKE DURING THE PROCESS. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH SUCTION AND FORCEPS. THE PROCEDURE WAS COMPLETED USING A CONMED COMPETITOR DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY GREATER THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437499 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE TIP OF THE BIOSURE SCREW BROKE AT THE TIME OF PUTTING INTO THE PATIENT. 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 19661249 ↗
• InjuryFeb 7, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL, A BIOSURE REGENESORB SCREW BROKE WHILE BEING INSERTED. THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT WITH THE HELP OF GRASPER. THE SURGICAL SITE WAS PREPARED WITH A GOLDEN OWL AND IT WAS CLEARED. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY OF LESS THAN 30 MINUTES, WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN A NEW DRILLED BONE HOLE. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 18663573 ↗
• MalfunctionDec 29, 2023Break; Break

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT OF THE KNEE USING QUADRICIPITAL TENDON, THE BIOSURE SCREW BROKE AND WAS ABNORMALLY FRAGILE. NO BROKEN PIECES WERE LEFT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. THERE WAS A SURGICAL DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18419476 ↗
• MalfunctionDec 8, 2023Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT SURGERY, THE BIOSURE REGENESORB SCREW BROKE EXTERNAL TO PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N 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 18291719 ↗
• MalfunctionNov 19, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN SURGEON WAS TIGHTENING THE BIOSURE SCREW IT BREAK. 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 18167314 ↗
• InjuryNov 9, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SCREW BIOSURE BROKE WHILE IMPLANTING AND ITS UPPER PART REMAINED SECURED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CURRENT STATUS IS WELL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18107358 ↗
• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY, THE BIOSURE SCREW BROKE WHILE BEING INSERTED. ALL PIECES WERE REMOVED FROM THE WOUND. THE S+N BACK UP DEVICE WAS USED IN THE SAME BONE HOLE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17999821 ↗
• MalfunctionJun 5, 2023Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE BIOSURE SCREW BROKE WHILE SCREWING IT IN. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059377 ↗
• InjuryOct 24, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE WAS DAMAGED DURING IMPLANTATION. ADDITIONAL TREATMENT WERE REQUIRED. A STAPLE WAS USED FOR ADDITIONAL FIXATION, BIOSURE INTERFERENCE SCREW WAS KEPT INSIDE THE TUNNEL, NO TRIAL TO REMOVE AND BROKEN PART WAS LEFT OUT. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN SURGICAL TECHNIQUE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15663072 ↗
• InjurySep 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIOSURE SCREW BROKE OFF DURING SCREW TIGHTENING. SURGERY WAS RESUMED WITHOUT ANY DELAY, USING A BACK-UP DEVICE IN THE ORIGINAL DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406625 ↗
• InjuryJan 10, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN AN UNSPECIFIED PROCEDURE, THE SCREW BIOSURE BROKE WHILE TIGHTENING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13211466 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ACL REPAIR SURGERY WITH A BIOSURE REGENESORB ABSORBABLE SCREW, THE PATIENT HAD A THROMBOSIS OF RIGHT LOWER EXTREMITY. THE EVENT WAS TREATED WITH RIVAROXABAN AND TRADITIONAL CHINESE MEDICINE. THE EVENT WAS RESOLVED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12683077 ↗
• InjuryMay 20, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ACL PLASTICS PROCEDURE, THE SCREW BROKE. A DELAY LESS OR EQUAL THAN 30 MINUTES WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11858269 ↗
• InjuryJun 9, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE BIOSURE REGENESORB 9 X 30MM WAS DIFFICULT TO INSERT, THE TIP FLATTEN AND CREAKED WHEN IT WAS REMOVED. THE DEVICE BREAK INSIDE THE PATIENT AND IT WAS RETRIEVED USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT A SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10136351 ↗
• MalfunctionMar 8, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE BIOSURE REGENESORB SCREW BROKE WHEN IT WAS BEING INSERTING INTO THE BONE TUNNEL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 9803856 ↗
• MalfunctionJan 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A AN ACL RECONSTRUCTION WHILE INSERTING THE SCREW IT BROKE AND PIECES WERE RETRIEVED WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 9594440 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142948. 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.