BIOSURE 72201786Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 03596010611826), received between Sep 28, 2018 and Feb 10, 2026 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K080358); 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC ACL RECONSTRUCTION, A BIOSURE HA 10MM X 30MM GOT BROKEN WHILE INTRODUCING INTO THE TIBIAL TUNNEL FOR GRAFT FIXATION. A 9MM INSTRUMENT WAS USED TO PREPARE THE INSERTION SITE, AND THE INSERTION SITE WAS CLEARED OF ALL DEBRIS PRIOR TO INSERTION. THE BROKEN PIECES WERE REMOVED FORM THE PATIENT WITH ARTERY FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310613 ↗
• MalfunctionSep 24, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIOSURE SCREW BROKE WHILE BEING PLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17805192 ↗
• InjuryOct 20, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, AFTER FIXING THE GRAFT, THE SURGEON REPOSITIONED THE BIOSURE SCREW AND THE TIP OF THE SCREW BROKE, EVEN AFTER FOLLOWING ALL THE RECOMMENDATIONS. THE BROKEN SCREW WAS RETIRED WITH THE PROPER INSTRUMENTAL. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639746 ↗
• InjuryOct 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIOSURE SCREW GOT PULLED OUT. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Rupture

  MAUDE report 15567900 ↗
• InjuryNov 25, 2021Break; Break

  IT WAS REPORTED THAT DURING ACL PROCEDURE, INTERNAL TO PATIENT, THE BIOSURE HEAD BROKE OFF WHEN IT WAS INSERTED, ALL PIECES WERE REMOVED FROM THE PATIENT BUT IT IS UNKNOWN HOW WERE THE PIECES RETRIEVE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12875264 ↗
• InjuryJun 17, 2021Break; Break

  IT WAS REPORTED THAT AFTER 10 DAYS OF LCA PROCEDURE, THE PATIENT STARTED TO FEEL PAIN IN PHYSIOTHERAPY, A PAIN THAT DID NOT IMPROVE. UPON RETURNING TO THE DOCTOR, HE REQUESTED A RESONANCE, WHERE IT WAS FOUND THAT THE SCREW WAS BROKEN. A NEW PROCEDURE WAS PERFORMED ON THE PATIENT ON (B)(6) 2021, WHERE A HIP GRAFT WAS INSERTED AND FIXED WITH NEW SCREWS AND A CORTICAL SCREW WAS ALSO USED TO SUPPORT THE EXISTING ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED CHANGING THE SURGICAL TECHNIQUE. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH A KELLY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient; Implant Pain; Pain

  MAUDE report 12021254 ↗
• InjurySep 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED TO REMOVE A BIOSURE HA SCREW FROM THE BONE AFTER ONE YEAR. A BONE CYST WAS FOUND DURING THE PROCEDURE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF A DELAY OCCURRED. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Cyst(s); Injury

  MAUDE report 10558124 ↗
• MalfunctionAug 21, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE SCREW WAS BEING INSERTED, THE TIP BROKE. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO SURGICAL DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8915157 ↗
• MalfunctionMay 22, 2019Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PASSAGE OF THE SCREW, THE SCREW LOST ITS ADHERENCE THAT ENVELOPED IT AND IT DID NOT ATTACH TO GRAFT, THE SCREW BROKE INSIDE THE PATIENT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8633212 ↗
• MalfunctionMay 7, 2019Break

  IT WAS REPORTED THAT THE SCREW WAS DAMAGED DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587792 ↗
• MalfunctionFeb 25, 2019Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE THE KNEE ARTHROSCOPY, AT THE TIME THAT THE SCREW WAS SET IN THE GRAFT IT BEGAN TO LOOSEN THE SCREW THREAD OF THE FILLETS. ADDITIONAL INFORMATION WAS RECEIVED AND WAS CONFIRMED THAT THE ANCHOR BROKE INSIDE THE PATIENT BUT ALL THE PIECES WERE REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8368974 ↗
• MalfunctionSep 28, 2018Material Frayed

  IT WAS REPORTED THAT WHEN THE THREADED BOLT IS STARTED, THE BOLT IS RELEASED FROM THE BOLT BODY, LEAVING A BURR AROUND THE TUNNEL, THE BOLT IS UNUSABLE AND REQUIRES ANOTHER BOLT. ALL PARTS WERE REMOVED FROM PATIENT AND THE SAME BONE HOLE WAS USED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7919396 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080358. 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.
• Z-1225-2012 · Feb 6, 2012 · Terminated
  Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue