BIOSURE 72204389Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885554036572), received between Apr 28, 2020 and Nov 3, 2025 — classified as 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (14 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 24, 2025Open, Classified

   Removal of affected lot of screws due to labeling error.

   Z-0957-2026 · Root cause: Packaging process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A MIDFOOT LIGAMENT INSERTION, AFTER THE INSERTION SITE WAS PREPARED WITH A 5 MM FEMORAL DRILL BIT, WHEN PLACING THE SCREWS USING AN ORANGE HANDLE, EVEN AFTER TAPPING WITH A 6 MM TAP, A 5X20 MM BIOSURE SCREW FRACTURED. THERE WERE NO FRAGMENTED PIECES LEFT INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY WITH A CHANGE IN SURGICAL TECHNIQUE BY FIXING THE TENDON USING SUPER SUTURE. A VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23453523 ↗
• MalfunctionJul 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A MMPRT PROCEDURE, ONE (1) BIOSURE REGEN SCREW 5 X 20MM FRACTURED WHEN IT WAS INSERTED INTO THE BONE HOLE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE USING THE ORIGINALLY DRILLED BONE HOLE AND LEAVING NO VOID IN THE PATIENT, THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. THERE WAS A DELAY OF FIVE (5) MINUTES, AND NO INJURIES OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385446 ↗
• MalfunctionApr 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A PATELLOFEMORAL RECONSTRUCTION, THE BIOSURE REGENESORB SCREW BROKE IN HALF. ONE HALF OF THE SCREW REMAINED IMPLANTED IN THE PATIENT, WHILE THE OTHER HALF WAS REMOVED USING APPREHENSION FORCEPS. DUE TO THIS, A CHANGE IN SURGICAL TECHNIQUE WAS REQUIRED, INVOLVING A LATERAL INCISION TO KNOT THE SUPER SUTURES AND A NEW LINE TO COMPLETE THE PROCEDURE. THERE IS A RISK OF PATELLOFEMORAL RECONSTRUCTION FAILURE, AS CONCERNS REMAIN REGARDING THE POTENTIAL FUTURE YIELD OF THE REMAINING HALF-SCREW. A 5X20 BALL TUNNEL AND A 6X20 BIOSURE SCREW WERE USED FOR THE INSERTION SITE PREPARATION. THE PROCEDURE WAS DELAYED BY LESS THAN 30 MINUTES, A VOID WAS LEFT AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Perforation

  MAUDE report 21757596 ↗
• MalfunctionMar 14, 2025Break; Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY PROCEDURE, ONE (1) BIOSURE REGENESORB 5 X 20 MM SCREW FRACTURED BEFORE THE SCREW SLID THOUGHT THE TUNNEL. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT WITH AN ADSON BROWN FORCEPS AND LONG STRAIGHT KELLY FORCEPS. SURGERY WAS COMPLETED WITH A BIOSURE REGENESORB 6 X 20 MM SCREW USED IN THE ORIGINALLY DRILLED BONE HOLE. A 5.0 MM CANNULATED FEMORAL DRILL WAS USED TO PREPARE THE INSERTION SITE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610124 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE REGENESORB SCREW BROKE WHEN IT WAS SCREWED IN, IT WAS REMOVED FROM THE PATIENT USING A GRASPER. THE PROCEDURE WAS COMPLETED WITH A FEMORAL FIXATION TECHNIQUE 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 18838730 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE BIOSURE SCREW WAS BROKE INTO PIECES WHEN SCREWED IN, ALL THE PIECES WERE REMOVED USING GRASPER, AND NO VOID WAS LEFT IN THE PATIENT. THE INSERTION SITE CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY AND A CHANGE IN SURGICAL TECHNIQUE WAS REQUIRED FROM DOUBLE FIXATION TO SINGLE FIXATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838727 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE REGENESORB IMPLANT BROKE UPON INSERTION. THE PIECES WERE REMOVED USING SUCTION AND TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18650523 ↗
• MalfunctionJan 8, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE REGENESORB SCREW FAILED; WHEN IT WAS FASTENING, IT BROKE. THE PROCEDURE WAS COMPLETED USING 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 18468300 ↗
• MalfunctionAug 13, 2023Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS REPAIR PROCEDURE, THE BIOSURE SCREW BROKE WHEN IT WAS BEING INSERTED INTO THE BONE HOLE. 1CM OF THE BROKEN SCREW TIP WAS LEFT SECURED INSIDE THE BONE HOLE, SINCE IT COULD NOT BE REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE. THE PROCEDURE WAS COMPLETED WITH A 10-MINUTE SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17538081 ↗
• InjuryFeb 9, 2023Break; Break

  IT WAS REPORTED THAT DURING A HAGLUND DEFORMITY REPAIR, WHERE A TENDON TRANSFER TECHNIQUE TO AUGMENT THE ACHILLES TENDON WAS USED; AFTER MEASURING THE GRAFT, DRILLING THE BONE TUNNEL AND PASSING THE GRAFT, WHEN THE GUIDE PIN OF A BIOSURE REGENESORB SCREW WAS ATTEMPTED TO BE INSERTED, THE SCREW SHATTERED AND THEREFORE WAS NOT USABLE. SURGERY CONTINUED WITHOUT ANY DELAY, AFTER THE BROKEN PIECES WERE REMOVED; WITH A S+N BACK-UP DEVICE BY REDRILLING WITH A CANNULATED DRILL TO INSERT A BICEPTOR TENODESIS SCREW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 16336779 ↗
• InjuryOct 4, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, A TOTAL OF TWO (2) 5X20MM BIOSURE SCREWS WERE BROKEN WHILE SCREWING, ALL THE PIECES WERE REMOVED BY GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536567 ↗
• MalfunctionFeb 18, 2022Break; Break

  IT WAS REPORTED THAT THE HEAD OF THE BIOSURE REGENESORB SCREW WAS BROKEN. IT IS UNKNOWN WHEN THE EVENT OCCURRED, IF THERE WAS A SURGICAL DELAY AND IF THERE WAS A PATIENT INVOLVED. THERE WAS A BACK-UP AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559448 ↗
• InjuryJan 4, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE REGENESORB SCREW BROKE INTO HALF. THE PIECES WERE REMOVED FROM THE PATIENT, IT WAS NECESSARY TO DRILL BIGGER AND USE A BIGGER SCREW AS A BACK-UP DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13153054 ↗
• InjuryMar 11, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHEN THE SCREW WAS SCREWED INTO THE TIBIAL DRILLING CHANNEL, THE SCREW SUDDENLY BROKE IN SEVERAL PARTS. THE SCREW PARTS WERE REMOVED FROM PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO SIGNIFICANT 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 11466786 ↗
• InjuryJan 13, 2021Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE SCREW BROKE UPON INSERTION TO THE FEMORAL TUNNEL. ALL PIECES WERE REMOVED FROM THE PATIENT WITH AN ARTHROSCOPIC GRASPERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11159567 ↗
• InjuryDec 3, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE SCREW BROKE, THE SURGEON PREPARED THE HOLE WELL WITH A 5MM DRILL BIT AND WAS VERY DELICATE DURING THE INSERTION. BROKEN PIECES WERE REMOVED WITH TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938166 ↗
• MalfunctionApr 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE SCREW WAS LOOSE AND COULD NOT BE FIXATED WHEN IT WAS INSERTED INTO THE BONE HOLE. NO PATIENT INJURIES OR DELAY REPORTED. ALTHOUGH NO BACKUP DEVICE IS REPORTED, THERE IS NO INFORMATION THAT REASONABLY SUGGESTS A PROCEDURE CANCELLATION, CHANGE IN SURGICAL TECHNIQUE NOR USE OF COMPETITOR DEVICE OCCURRED. 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 10003826 ↗