BIOSURE 72204398Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00885554036749), received between Sep 30, 2019 and Mar 26, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Fracture

  IT WAS REPORTED THAT, DURING AN ACL KNEE ARTHROSCOPY, ONE (1) BIOSURE REGENESORB SCREW FRACTURED AS IT WAS BEING POSITIONED FOR IMPLANTATION. NO PIECES FELL INSIDE OF THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY 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 24699686 ↗
• MalfunctionApr 10, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN THE CANAL WAS BEING OPENED AND THE BIOSURE REGENESORB WAS SCREWED IT OPENED IN TWO. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES. THE PATIENT'S HEALTH CONDITION IS STABLE, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19080694 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE REGENESORB SCREW WAS FOUND BROKEN DURING THE HALFWAY IN THE BONE TUNNEL WHILE THE SURGEON WAS TRYING TO SCREW IN THE REMAINING SCREW. HALF OF THE SCREW REMAINED INSIDE THE PATIENT AND THE OTHER HALF WAS REMOVED. THE SURGEON OPENED A NEW BIOSURE REGENESORB SCREW TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18951611 ↗
• MalfunctionDec 13, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, IN THE INTRODUCTORY PHASE IN THE TIBIAL TUNNEL, THE SCREW BIOSURE BROKE WITHOUT FORCING THE SYSTEM. IT IS UNKNOWN IF THERE WAS A BACK UP DEVICE AVAILABLE. 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 18320085 ↗
• MalfunctionDec 6, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BIOSURE SCREW BROKE. THE PROCEDURE WAS COMPLETED SING A S+N BACK UP DEVICE. 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 18279346 ↗
• InjuryNov 18, 2020Break; Break

  IT WAS REPORTED THAT DURING A SURGERY WHILE THE FEMORAL TUNNEL WAS DRILLED, THE BIOSURE REGENESORB WIRE WAS INSERTED AND 8 MM TAP WAS UTILIZED. DURING THE INSERTION OF THE SCREW, IT BROKE INTO MULTIPLE PIECES. ALL THE PIECES WERE REMOVED FORM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT A SIGNIFICANT DELAY USING A 9MM CANNU FLEX SILK SCREW AS A BACKUP 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: No Consequences Or Impact To Patient

  MAUDE report 10865722 ↗
• InjuryOct 1, 2019Patient-Device Incompatibility

  IT WAS REPORTED THAT AFTER A KNEE ARTHROSCOPY ACO RECONSTRUCTION PROCEDURE, THE PATIENT IS HAVING AN ALLERGIC REACTION TO THE SCREW. THE SKIN IS BREAKING DOWN AND PUSHING PIECES OF THE SCREWS OUT. THE ADVERSE EVENT WAS TREATED WITH THE REMOVAL OF PIECES AND IRRIGATION AND DEBRIDEMENT.

  Patient problems: Hypersensitivity/Allergic reaction; Tissue Breakdown

  MAUDE report 9142282 ↗
• InjurySep 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY ((B)(6) 2018), PATIENT HAD SOME SORT OF FOREIGN BODY REACTION TO THE SCREWS. PATIENT WAS TREATED ON ((B)(6) 2019) WITH A REVISION SURGERY TO REMOVE THE ANCHORS. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Foreign Body Reaction

  MAUDE report 9137743 ↗

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.