BIOSURE 72204392Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885554036688), received between Feb 24, 2020 and Mar 6, 2026 — classified as 2 injuries, 12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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) 2025, 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, IT WAS UNSCREWED FROM THE 7X30 MM CANAL, DUE TO IT WAS PALPABLE AND MOBILE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY IN (B)(6) 2026 TO REMOVE THE SCREW. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration; Pain; Subcutaneous Nodule

  MAUDE report 24538503 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPIC PROCEDURE, THE BIOSURE SCREW WAS BROKEN WHILE SCREWING IT IN, THE BROKEN PIECES WERE REMOVED USING A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP IN THE SAME HOLE, NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED, PATIENT IS DOING GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268381 ↗
• MalfunctionNov 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN MPFL, WHEN PUTTING THE SCREW BIOSURE REGENESORB ON THE FEMORAL BONE, THE SCREW BROKE IN HALF. THE BROKEN PIECES WERE REMOVED USING TWEEZERS AND A GRASPER. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT SN BACK-UP IN THE ORIGINALLY DRILLED BONE HOLE; NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23659071 ↗
• MalfunctionNov 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A MCL RECONSTRUCTION PROCEDURE, THE 6.0 MM BIOSURE SCREW WAS FRACTURED WHEN INSERTED INTO A 6.5 MM BONE TUNNEL. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITH A 15 MINUTE DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598555 ↗
• MalfunctionAug 18, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE INSERTION, THE BIOSURE SCREW BROKE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT USING GRASPER AND TWEEZERS. THE SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827471 ↗
• MalfunctionJul 22, 2025Break; Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, AFTER THE INSERTION SITE WAS PREPARED WITH A DRILL BIT, THE BIOSURE SCREW BROKE WHEN IT WAS PLACED IN THE BONE HOLE. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD, WHICH WAS USED IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22565663 ↗
• 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 21749182 ↗
• 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 21251730 ↗
• MalfunctionJul 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACHILLES TENDON REPAIR, WHEN PLACING THE BIOSURE SCREW IN THE HOLE ALREADY DRILLED, THE IMPLANT FRACTURED IN SEVERAL PARTS, ONLY A PART OF THE IMPLANT REMAINED INSIDE THE HOLE, THE OTHER PARTS COULD BE RECOVERED. WHEN PLACING THE IMPLANT, IT DAMAGED THE AUTOGRAFT AT THE TIME OF PLACEMENT. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY GREATER THAN 30 MINUTES, AND USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Damage to Ligament(s); Device Embedded In Tissue or Plaque

  MAUDE report 19851512 ↗
• 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 17322133 ↗
• MalfunctionJun 24, 2023Break; Break

  IT WAS REPORTED THAT DURING A MPFL, THE BIOSURE BROKE DURING ADVANCEMENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17196087 ↗
• MalfunctionJul 30, 2022Crack; Crack

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, WHEN THE DRIVER WAS INSERTED INTO THE SCREW BIOSURE REGENESORB, THE SCREW CRACKED. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136740 ↗
• InjuryOct 22, 2020Break; Break

  IT WAS REPORTED THAT UPON IMPLANTATION INTO THE CALCANEUM PRE DRILLED TUNNEL (6MM DIAMETER) TO SECURE THE FHL TENDON, THE PRODUCT BREAKS INTO PIECES. THE ISSUE WAS COMPLETED WITH A BACK-UP IMPLANT (SMITH AND NEPHEW BIOSURE HA SCREW 6 X 25MM). BROKEN PIECES OF THE IMPLANT WERE TAKEN OUT AND THERE WAS NO PATIENT HARM CAUSED. HOWEVER, THE PROCEDURE WAS DELAYED FOR ANOTHER 15MIN. NO ADDITIONAL BONE HOLES WERE REQUIRED. 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 10718842 ↗
• MalfunctionFeb 24, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING POSTERIOR LATERAL CORNER SURGERY THE SCREW BROKE INTO SMALL PIECES INSIDE THE JOINT. THE BROKEN PIECES WERE REMOVED WITH FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR 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 Known Impact Or Consequence To Patient

  MAUDE report 9748563 ↗

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.