BIOSURE 72204391Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885554036671), received between Jan 4, 2018 and Jan 5, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT, DURING A LIGAMENT STABILIZATION PROCEDURE, THE BIOSURE SCREW BROKE WHILE BEING SCREWED IN. THE BROKEN PIECES WERE REMOVED USING ARTHROSCOPIC FORCEPS AND A SHAVER. THE PROCEDURE WAS RESUMED, WITH A NON SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP. THE BACK UP DEVICE WAS USED IN THE SAME BONE HOLE AND NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23960713 ↗
• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE BIOSURE SCREW BROKE OFF DURING IMPLANTATION. SURGERY WAS COMPLETED WITH A BACK-UP 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 22088239 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL KNEE ARTHROSCOPY, THE BIOSURE REGENESORB SCREW BROKE INSIDE THE TUNNEL AND CRUMBLED, BREAKING COMPLETELY. THERE WAS FRAGMENTATION INSIDE THE PATIENT; HOWEVER, ALL THE FRAGMENTS WERE REMOVED USING A KELLY INSTRUMENT. THE REMAINING FRAGMENTS FELL TO THE FLOOR. THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, AND THERE WAS NO SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21759245 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY A BIOSURE REGENESORB SCREWS BROKE WHILE BEING SCREWED IN, DESPITE THE PROPERLY PREPARED BONE HOLE. A BACK DEVICE WAS USED IN THE ORIGINAL DRILLED BONE HOLE. ALL THE ELEMENTS WERE REMOVED FROM THE JOINT. 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 21749183 ↗
• MalfunctionJan 28, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A BIOSURE REGENESORB SCREW BROKE WHILE SCREWING IN. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED WITH AND IF THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE. ELEMENTS WERE REMOVED FROM THE JOINT. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251767 ↗
• MalfunctionJun 26, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, A BIOSURE REGENESORB SCREW BROKE WHEN SCREWING IT INTO THE CANAL. THE BROKEN PARTS WERE REMOVED FROM THE JOINT. IT IS UNKNOWN IF THERE WERE A BACK-UP DEVICES AVAILABLE OR HOW THE PROCEDURE WAS COMPLETED. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19621181 ↗
• MalfunctionMar 5, 2024Crack; Crack

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIOSURE REGENESORB TIP CRACKED AT THE TIME OF INSERTION. THE PROCEDURE WAS COMPLETED USING A S+N BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839582 ↗
• MalfunctionJan 15, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE BIOSURE SCREW BROKE WHEN PLACING IT IN THE SCREWDRIVER, THE TIP OF THE IMPLANT WAS NOT OPEN ENOUGH FOR THE SCREWDRIVER TO ENTER. THE PROCEDURE WAS COMPLETED WITH NO DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18511209 ↗
• MalfunctionJan 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW FRACTURED IN THE FIRST TURN AND BROKE IN THE MIDDLE. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT CURRENT STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498142 ↗
• MalfunctionJul 13, 2023Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE SCREW COULD NOT BE PLACED AS IT SHOULD, WHICH RESULTED IN THE BREAKAGE OF THE BIOSURE REGENESORB SCREW USED DURING THE PROCEDURE. SURGERY WAS COMPLETED AFTER A 20-MINUTE DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT'S STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322136 ↗
• MalfunctionMay 10, 2023Break; Break

  IT WAS REPORTED DURING AN ARTHROSCOPY, THE BIOSURE REGENESORB SCREW BROKE WHILE SCREWING IN. ALL THE PIECES WERE REMOVED FROM THE PATIENT. NON-SIGNIFICANT SURGICAL DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE USED IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906745 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW WAS FOUND TO BE BROKEN WHEN THE PRODUCT'S PACKAGE WAS OPENED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324920 ↗
• InjuryJan 12, 2022Crack; Crack

  IT WAS REPORTED THAT DURING A MCL PROCEDURE, WHEN INSERTING THE BIOSURE SCREW, THE SCREW'S HEAD CRACKED. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236817 ↗
• InjuryDec 20, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE SCREW BIOSURE REGENESORB BROKE WHEN IT WAS TRIED TO INSERT IT INTO THE BONE HOLE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043433 ↗
• MalfunctionMay 4, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT AFTER THE ARTHROSCOPY PROCEDURE, THE NURSE REALIZED SHE HAD GIVEN THE FIELD AND EXPIRED IMPLANT. PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO DELAY AND NO PATIENT 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11773758 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, AFTER DEPLOYING OF THE SCREW BIOSURE REGENESORB 6MM X 20MM, THE DEVICE HAD A BREAK IN THE PROXIMAL PART. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO DELAY NOR PATIENT INJURY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11592776 ↗
• MalfunctionNov 9, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE BIOSURE'S PACKAGE WAS OPENED IT WAS NOTICED THE PRODUCT WAS BROKE. THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY OR PATIENT INJURY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10813609 ↗
• MalfunctionMar 29, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING VKB SURGERY, THE SCREW BROKE DURING INSERTION INTO THE FEMORAL DRILL CHANNEL. THE BROKEN PIECE WAS REMOVED WITH TWEEZERS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES. 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 9896119 ↗
• MalfunctionDec 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE THE SCREW BROKE. IT IS UNKNOWN IF THERE WAS A DELAY OR BACK-UP DEVICE AVAILABLE. NO PATIENT INJURIES 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 9443029 ↗
• MalfunctionDec 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE THE SCREW BROKE. IT IS UNKNOWN IF THERE WAS A DELAY OR BACK-UP DEVICE AVAILABLE. NO PATIENT INJURIES 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 9443028 ↗
• MalfunctionJan 4, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7163960 ↗
• MalfunctionJan 4, 2018Break

  IT WAS REPORTED THAT THE SCREW BROKE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7163950 ↗

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.