BIOSURE 72204390Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885554036664), received between Feb 12, 2019 and Apr 18, 2026 — classified as 9 injuries, 10 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. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, ONE (1) BIOSURE REGENSORB SCREW BROKE DURING INSERTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACKUP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24919772 ↗
• 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 5X25 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 23453835 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT, DURING AN EXTRA-ARTICULATE ITB TENODESIS - KNEE SURGERY, TWO (2) BIOSURE REGENESORB INTERFERENCE SCREWS (5X25MM) BROKE INTO PIECES INSIDE THE PATIENT. THE GRAFT WAS SECURED WITH A 6X25 RG SCREW INSTEAD. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. THE BACK UP DEVICE WAS USED IN THE ORIGINALLY DRILLED HOLE. ALL THE PIECES WERE REMOVED BY PICKING THEM OFF BY HAND, AND WASHING THE AREA WITH SALINE. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413965 ↗
• MalfunctionSep 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE BIOSURE SCREW BROKE INTO PIECES WHEN IT WAS SCREWED IN. THE BROKEN PIECES WERE REMOVED FROM INSIDE THE PATIENT USING TWEEZERS AND A SHAVER. THE PROCEDURE WAS COMPLETED PLACING A S+N BACK UP DEVICE INTO THE ORIGINALLY BONE 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 22993031 ↗
• MalfunctionOct 20, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW TIP BROKE OFF DURING INSERTION INTO THE PATIENT. THE SCREW HAS BEEN TAKEN OUT FROM THE PATIENT¿S BODY USING FORCEPS. THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION OF THE ANCHOR. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE WITH THE SAME DIAMETER IN THE SAME DRILLED HOLE, AND NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490316 ↗
• MalfunctionMar 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE BIOSURE SCREW BROKE WHEN IT WAS INSERTED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. THE PATIENT'S CONDITION HEALTH IS STABLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18988821 ↗
• 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 18468547 ↗
• MalfunctionDec 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE REGENESOR SCREW FRACTURED WHILE BEING INSERTED. THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18414399 ↗
• InjuryNov 17, 2022Break; Break

  IT WAS REPORTED THAT DURING A LATERAL COLATERAL LIGAMENT RECONSTRUCTION, WHERE THE INSERTION SITE WAS PREPARED WITH A 4.5MM CANNULATED DRILL, WHEN THE SURGEON ATTEMPT TO INSERT A BIOSURE REGENESORB SCREW 5X20MM INTO THE FIBULA USING THE SMALL ORANGE HANDLE BIOSURE DRIVER; UPON INSERTION THE SCREWS THREADS BROKE APART. ALL THE BROKEN THREADS WERE REMOVED USING FORCEPS. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY. WITH A BACK-UP 5X20MM RCI PK HA WITH A STANDARD BIOSURE SCREWDRIVER, WHICH WORKED PERFECTLY, IN THE ORIGINALLY DRILLED BONE, THEREFORE NO VOIDS WERE LEFT IN THE PATIENT. PATIENT IS ON GOOD HEALTH CURRENTLY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15811904 ↗
• InjuryNov 1, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF THE BIOSURE REGENESORB SCREW BROKE OFF DURING TIGHTENING. THE BROKEN PIECE WAS RETRIEVED USING FORCEPS. SURGERY WAS COMPLETED WITHOUT DELAY, USING A BACK-UP DEVICE IN THE ORIGINAL DRILLED BONE HOLE. PATIENT'S HEALTH STATUS IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710071 ↗
• InjuryJul 29, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE 5X25MM BIOSURE REGENESORB SCREW BROKE OFF DURING SCREW TIGHTENING. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT USING GRASPERS THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. IT WAS REPORTED THAT THE PATIENT IS RECOVERING WELL FROM THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15135747 ↗
• InjuryApr 12, 2022Break; Break

  IT WAS REPORTED THAT DURING MCL SURGERY, WHILE INSERTING THE SCREW IN THE TUNNEL, THE SCREW BROKE. NON-SIGNIFICANT DELAY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NON-SIGNIFICANT DELAY WAS REPORTED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14087899 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE SURGERY IT WAS NOTICE THAT AN EXPIRED BIOSURE WAS IMPLANTED IN THE PATIENT. NO OTHER COMPLICATION REPORTED. NO DELAY WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. 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 11070146 ↗
• 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 10938197 ↗
• 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 10938163 ↗
• InjuryNov 19, 2020Break; Break

  IT WAS REPORTED THAT DURING MPFL SURGERY, THE SCREW BIOSURE REGENESORB BROKE INTO TWO PIECES DURING INSERTION. THE RIGHT SCREWDRIVER (5MM) WAS USED IN THE RIGHT WAY AND WITHOUT EXCESSIVE FORCE. THE BROKEN PIECES WERE REMOVED WITH TWEEZERS. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR OTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10871519 ↗
• InjuryNov 9, 2020Break; Break

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A LCL REPAIR AND WENT TO INSERT THE 5 X 25MM BIOSURE REGEN SCREW AND THE SCREW DETHREADED, IT LOOKED LIKE IT MAY HAVE FRACTURED AT THE TIP. THE MALFUNCTION WAS SOLVED REDRILLING THE HOLE TO INSERT A 6 X 25 MM SCREW, A DELAY SHORTER THAN 30 MINUTES AND NO PATIENT HARM WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10807285 ↗
• MalfunctionSep 9, 2020Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SCREW BROKE IMMEDIATELY WHEN THE SCREW WAS INSERTED TO THE DRIVER. NO PATIENT INJURY OR DELAY WAS 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 10511739 ↗
• MalfunctionFeb 12, 2019Break

  IT WAS REPORTED THAT DURING THE SURGERY THE SCREW GOT BROKEN WHILE IT WAS BEING SCREWED. NO PATIENT INJURIES WERE REPORTED. IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE AND IF THERE WAS A DELAY OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8332918 ↗

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.