BIOSURE 72204394Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885554036701), received between Jun 29, 2018 and Jun 22, 2026 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT, DURING AN ACL SURGERY, WHILE INSERTING ONE (1) 7 MM X 20 MM BIOSOURCE REGENESORB SCREW INTO THE TIBIAL TUNNEL, THE SCREW THREADS WERE DAMAGED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25588123 ↗
• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL, THE BIOSURE SCREW GOT BROKEN WHILE INSERTING IT. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR SN BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919931 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL BIOSURE KNEE ARTHROSCOPY, THE NITINOL GUIDE WIRE WAS PASSED AND THE SCREW BIOSURE REGENESORB 7MM X 20MM WAS INSERTED INTO THE TUNNEL, AND BEFORE THE SCREW WAS FULLY INSERTED, IT BROKE. A 6.5MM TUNNEL, BIOSURE SCREWDRIVER WAS USED TO PREPARE THE INSERTION SITE, IT WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH A KELLY FORCEPS. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING AN EQUIVALENT S+N BACK-UP USED IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974017 ↗
• MalfunctionJan 21, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIOSURE SCREW BROKE DURING SCREWING. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE, HOWEVER, THE PROCEDURE WAS COMPLETED USING THE SAME DRILLED BONE HOLE, NO VOIDS WERE LEFT, AND THE BROKEN PIECES WERE REMOVED FROM THE JOINT. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200350 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED THAT, DURING ACL PROCEDURE, THE BIOSURE REGENESORB SCREW BROKE WHEN IT WAS INSERTED. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD AND A SURGICAL DELAY GREATER THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20751497 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, A FEMORAL PERFORATION OF 8.5 X 25MM WAS PERFORMED, GRAFT AND NITINOL GUIDE WERE PASSED AND A SCREW BIOSURE REGENESORB 7MM X 20MM WAS PASSED, WHEN IT STARTED TO BE SCREWED, A SOUND WAS HEARD AND IT WAS OBSERVED THAT IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE AND A CHANGE IN THE SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906125 ↗
• MalfunctionMay 13, 2024Break; Break

  IT WAS REPORTED THAT DURING A ACL MENISCAL REPAIR, THE BIOSURE REGENESORB SCREW BROKE WHEN IT WAS PLACED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH 2 HOURS OF SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305033 ↗
• MalfunctionNov 1, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, TWO BIOSURE REGENESORB SCREWS FAILED. WHEN THE FIRST SCREW WAS BEING SCREWED INTO PLACE IT BROKE INTO MULTIPLE PIECES. A BACKUP SCREW FROM THE SAME LOT NUMBER WAS THEN USED; UPON ENTERING THE JOINT, WITHOUT PLACING MUCH TORQUE, IT BROKE AS WELL IN MULTIPLE PIECES. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT BY SUCTION FROM A SHAVER. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO VOID WAS LEFT INSIDE THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT STATUS OF THE PATIENT IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18051787 ↗
• MalfunctionMay 26, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW BROKE DURING INSERTION. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT'S JOINT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17014659 ↗
• MalfunctionApr 13, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, WHILE SECURING A GRAFT, A BIOSURE SCREW WAS ATTEMPTED BUT IT BURST. ALL PIECES WERE REMOVED FROM THE PATIENT USING HANDS AND SURGICAL INSTRUMENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMALLER SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT IS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732322 ↗
• InjuryJan 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION (BTB-AUTOGRAFT TECHNIQUE) SURGERY THE SCREW BIOSURE REGENESORB BROKE INSIDE THE PATIENT'S FEMUR. APPROXIMATELY 5MM-7MM WAS REMOVED OF THE BROKEN SCREW AND THE REMAINING SCREW WAS LEFT IN PLACE WITH SECURE FIXATION. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY AND A BACKUP DEVICE WAS AVAILABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16103819 ↗
• InjuryNov 28, 2022Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE, A FEMORAL TUNNEL WAS PERFORMED, WHERE A SCREW BIOSURE REGENESORB WAS GOING TO BE POSITIONED WITH ITS RESPECTIVE SCREWDRIVER, HOWEVER IT DID NOT FIT PROPERLY, THEREFORE THE PHYSICIAN DECIDED TO USE THE FIXED SCREWDRIVER, BUT THE SAME ISSUE PERSISTED, NOT ALLOWING THE COMPLETE INSERTION OF THE SCREW. AFTER TRYING SEVERAL TIMES, THE ORANGE HANDLE OF THE BIOSURE WAS USED, THE SCREW ENTERED COMPLETELY IN THE HANDLE, BUT AT THE MOMENT OF PLACING THE SCREW IN THE FEMUR, IT STOPPED ADVANCING, EVEN AFTER FORCE WAS APPLIED IT TO PUSH IT. THE SCREW SEEMED TO ROLL, THEREFORE, IT WAS TRIED TO BE WITHDRAWN, BUT THE DISTAL PART OF THE SCREW BROKE AND CAME OUT. AN ATTEMPT WAS MADE TO REMOVE THE ENTIRE SCREW, HOWEVER IT WAS NOT POSSIBLE TO EXTRACT IT, REMAINING INSIDE THE FEMUR, APPROXIMATELY 60% OF THE IMPLANT. SURGERY WAS COMPLETED AS MENTIONED WITH A NON-SIGNIFICANT DELAY, WITH THE REPORTED DEVICE. PATIENT´S HEALTH CONDITION WAS NOT AFFECTED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15867696 ↗
• InjuryJul 21, 2022Break; Break

  IT WAS REPORTED THAT, DURING A LATERAL TENODESIS, THE BIOSURE REGENESORB SCREW SHATTERED WHILE ADVANCING. ALL PIECES WERE REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS VERY GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15076231 ↗
• InjuryOct 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING RECONSTRUCTION OF A PCL, INSIDE THE PATIENT, 7 MM DIAMETER FEMORAL AND TIBIAL TUNNELS WERE CARVED AND THE RESPECTIVE FIXATION OF THE GRAFT TO THE BONE (FEMORAL CONDYLE) WAS CARRIED OUT WITH SCREW BIOSURE REGENESORB 7MM X 20MM. WHEN THE SCREW WAS PASSED, IT ABUSED THE GRAFT TERRIBLY, CAUSING SOME FIBERS TO BREAK AND THE DIAMETER OF THE GRAFT TO BE SMALLER. TO PREVENT THE GRAFT FROM BREAKING COMPLETELY, THE FEMORAL FIXATION IS NOT PERFORMED IN A CONVENTIONAL MANNER, BUT INSTEAD, THE SURGICAL TECHNIQUE WAS CHANGED AND A 4.5 MM CORTICAL SCREW POST FROM ANOTHER COMMERCIAL COMPANY WAS USED. THE DEVICE WAS USED TO PERFORM TIBIAL FIXATION. IT IS UNKNOWN IF A DELAY OCCURRED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12724407 ↗
• InjuryOct 4, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION WITH A HAMSTRING GRAFT, WHEN FIXING THE GRAFT AT THE FEMORAL LEVEL WITH BIOSURE REGENESORB INTERFERENCE SCREWS, IT WAS NOTICED THAT THE GRAFT WAS DAMAGED WHEN IT WAS PASSED THROUGH, WEARING IT DOWN AND RELEASING FIBERS FROM IT. HOWEVER, THE PROCESS WAS ENDED AND IMMEDIATELY AFTER ADVANCING THE SCREW BETWEEN THE GRAFT AND THE TUNNEL, A LITTLE RESISTANCE WAS EVIDENT AND THE SCREW BROKE INSIDE THE PATIENT, LEAVING CHIPS AND A SENSATION OF FALSE FEMORAL FIXATION. STABILITY TESTS WERE PERFORMED ON THE PATIENT AND THERE WAS NO EVIDENCE OF LAXITY, SO THE SCREW WAS LEFT INSIDE THE TUNNEL AND THE CHIPS WERE RETRIEVED FROM PATIENT. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

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

  MAUDE report 12567787 ↗
• MalfunctionJun 29, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING AN ACL, THE INTERFERENCE SCREW DID NOT MEET THE SURGEON NEEDS, IT CRACKED SO THE SCREWDRIVER KEPT SPINNING IN THE SCREW. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO MAJOR DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7649970 ↗

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.