BIOSURE 72204412Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00885554036886), received between Aug 31, 2018 and Feb 11, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY ACL, WAS PREPARED, PASSED THROUGH THE TUNNELS, AND FIRST FIXED IN THE FEMORAL TUNNEL. THEN, THE GRAFT WAS FIXED IN THE TIBIAL TUNNEL. A 9MM TAP WAS USED BEFOREHAND, AND AN 11X30MM BIOSURE SCREW WAS INSERTED. AS THE BIOSURE SCREW WAS BEING INSERTED, IT WAS NOTICED SPIRAL-SHAPED FRAGMENTS DETACHING, WHICH INITIALLY THOUGHT WERE SUTURE MATERIAL. HOWEVER, THESE WERE ACTUALLY FRAGMENTS OF THE SCREW ITSELF. THE SCREW WAS FULLY INSERTED AND APPEARED TO BE SECURE, BUT UPON INTRA-ARTICULAR INSPECTION, THE GRAFT WAS FOUND TO BE COMPLETELY LOOSE. THEREFORE, THAT SCREW HAD TO BE REMOVED. ALL THE PIECES WERE REMOVED FROM THE PATIENT WITH A KELLY CLAMP. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. THE INSTRUMENT TO PREPARE THE INSERTION SITE WAS A CANNULATED TIBIA DRILL BIT. THE PATIENT WAS NOT EXPOSED TO ADDITIONAL ANESTHESIA. THE PATIENT IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314526 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW GOT DAMAGED DURING THE DEPLOY. 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 22750096 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE REGENESORB 11MM X 30MM SCREW BROKE WHEN THE SURGEON PUT THE SCREW IN THE PILOT HOLE. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22716088 ↗
• MalfunctionMar 31, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE SURGEON WAS DEPLOYING THE BIOSURE SCREW, IT GOT BROKEN AND WAS REMOVED USING THE STANDARD PROCEDURE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THE BACK UP DEVICE WAS USED IN THE ORIGINAL DRILLED 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 21734174 ↗
• MalfunctionMar 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY, WHEN THE SURGEON WAS DEPLOYING THE SCREW BIOSURE,IT BROKE. THE DEVICE WAS REMOVED IT AND THERE WAS A SMITH AND NEPHEW BACK UP SCREW. NO SURGICAL DELAY WAS REPORTED OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21613814 ↗
• MalfunctionJan 7, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE SCREW BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING GRASPERS. NO VOID WAS LEFT ON THE PATIENT. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE INTO AN ADDITIONAL BONE HOLE. THERE WAS A SURGICAL DELAY OF 10 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Perforation

  MAUDE report 21096213 ↗
• InjuryOct 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN TRYING TO PUT IN THE BIOSURE REGENESORB SCREW IN TIBIA, IT BROKE. ALL THE BROKEN PIECES WERE REMOVED USING SUCTION AND GRASPER. NO SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15581713 ↗
• InjuryApr 12, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHEN THE SPECIALIST WENT TO REMOVE THE DRIVER, THE SCREW WAS IMPACTED IN IT AND IT WAS OBSERVED THAT THE SCREW BROKE IN THE THREAD IN THE CENTRAL PORTION. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT BUT IT IS UNKNOWN HOW. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14088749 ↗
• InjuryDec 14, 2021Break; Break

  IT WAS REPORTED THAT DURING ACL PROCEDURE, INTERNAL TO PATIENT, THE SCREW FAILED TO BE PLACED, IT DID NOT FIT AND BROKE OFF, THE BROKEN PIECES WERE REMOVED USING KELLY FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13002911 ↗
• InjuryAug 31, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SHOWS CYSTIC FORMATION AROUND THE TIBIAL SCREW ON MRI AT A FOLLOW UP APPT.

  Patient problems: Cyst(s)

  MAUDE report 7838705 ↗
• InjuryAug 31, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT SHOWS CYSTIC FORMATION AROUND THE TIBIAL SCREW ON MRI AT A FOLLOW UP APPT.

  Patient problems: Cyst(s)

  MAUDE report 7838697 ↗

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.