BIOSURE 72204397Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885554036732), received between Jul 16, 2019 and Mar 12, 2026 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Fracture

  IT WAS REPORTED THAT AFTER A RECONSTRUCTION OF THE MEDIAL PATELLOFEMORAL PATELLAR LIGAMENT (MPFL) PERFORMED ON (B)(6) 2024, IN WHICH A BIOSURE SCREW WAS IMPLANTED, THE PATIENT EXPERIENCED PAIN AT THE SITE OF SCREW FIXATION. THE EVENT WAS RESOLVED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH CRUMBS AT THE DISTAL PART OF THE SCREW WERE REMOVED. PATIENT OUTCOME REMAINS UNKNOWN.

  Patient problems: Pain

  MAUDE report 24579440 ↗
• InjuryMar 6, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A MEDIAL PATELLOFEMORAL LIGAMENT SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED INTERFERENCE SCREW IMPLANTATION, 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. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY IN (B)(6) 2026 TO REMOVE THE SCREW CRUMBS. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN, HOWEVER, THERE WERE NO PATIENT COMPLAINTS.

  Patient problems: Pain

  MAUDE report 24538235 ↗
• InjuryMar 3, 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. IN 2024, THE PATIENT UNDERWENT AN OPERATION TO REMOVE THE SCREW CRUMBS. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 24498604 ↗
• MalfunctionDec 3, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION THE SCREW BIOSURE BROKE DURING INSERTION, THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SIMILAR S+N BACK-UP DEVICE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706186 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, A 8 MM THICKNESS PERFORATION WAS PERFORMED ON THE TIBIA, NITINOL AND THREADING GUIDE OF 6 MM WERE PASSED AND WHEN SCREWING THE BIOSURE SCREW, IT BROKE IN HALF. ALL PIECES WERE REMOVED USING TWEEZERS. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD, IN THE SAME HOLE. 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 20236670 ↗
• MalfunctionAug 26, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE SCREW BROKE UPON INSERTION INTO THE ACL TUNNEL. ALL THE BROKEN PIECES OF THE SCREW WERE SUCCESSFULLY REMOVED FROM THE PATIENT AND A BACK UP SCREW OF THE SAME SIZE WAS USED TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20070678 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE REGENESORB SCREW BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED USING A SCREW BACK UP DEVICE IN THE SAME ORIGINAL DRILLED BONE HOLE, NO VOID WAS LEFT IN THE PATIENT. THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813223 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE BIOSURE REGENESORB INTERFERENCE SCREW BROKE AT THE TIP UPON THE INITIAL SCREWING, DESPITE THE SURGEON DOING THE NECESSARY TECHNIQUE DURING THE IMPLANTATION. ALL BROKEN PIECES WERE REMOVED USING FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY OF 5 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140434 ↗
• InjuryAug 9, 2023Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE; A BIOSURE REGENESORB SCREW BROKE WHILE BEING INSERTED. SURGERY CONTINUED WITH THE SAME 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 17494599 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT, DURING A RIGHT MEDIAL COLLATERAL LIGAMENT RECONSTRUCTION, WHEN THE SCREW DRIVER WAS BEING TURNED, THE BIOSURE SCREW SHATTERED INTO PIECES OUTSIDE THE REAMED BONE TUNNEL. SURGERY WAS COMPLETED AFTER A 5-MINUTE DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020161 ↗
• InjuryAug 11, 2021Break; Shielding Failure; Break; Shielding Failure

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, DURING THE SCREW TIGHTENING INTO THE TIBIAL CANAL ALONG THE NITINOL GUIDE, THE DISTAL PORTION OF THE BIOSURE SCREW BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT USING AN ARTHROSCOPIC GRASPER. A SURGICAL DELAY GREATER THAN 30 MINUTES WAS REPORTED AND THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310479 ↗
• InjuryJul 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 6 WEEKS AFTER A RECONSTRUCTION OF THE ANTERIOR CRUCIATE SURGERY, THE PATIENT HAD A INFILTRATION AT THE SITE OF A POSTOPERATIVE WOUND ON THE ANTERIOR SURFACE OF THE TIBIA; THE BODY TEMPERATURE DID NOT INCREASE. THE PATIENT RECEIVED ANTI-INFLAMMATORY TREATMENT, WITHOUT EFFECT. AN AUTOPSY OF THE FORMATION IN THE POSTOPERATIVE CICATRIX WAS PERFORMED, A CLOUDY, MUCUS-FIBROUS CONTENT OF WHITE-YELLOW COLOR WAS OBTAINED. CURRENT PATIENT STATUS IS GOOD.

  Patient problems: Unspecified Infection

  MAUDE report 8792041 ↗

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.