BIORCI 7207675Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010459930), received between Sep 25, 2017 and Jun 9, 2025 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, ONE (1) BIORCI-HA SCREW BROKE DOWN WHILE INSERTION TO TIBIAL SITE. THE PROCEDURE WAS RESUMED, AFTER A DELAY LESS THAN OR EQUAL TO 30 MINUTES, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168467 ↗
• MalfunctionApr 11, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THERE WAS BREAKAGE OF THE BIORCI-HA SCREW. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19094237 ↗
• MalfunctionDec 5, 2023Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BIORCI SCREW BREAK DURING DEPLOYMENT. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED AND IF THERE WAS A SURGICAL DELAY DUE TO THE REPORTED EVENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267505 ↗
• MalfunctionJun 23, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIORCI-HA BROKE WHEN IT WAS INSERTED INTO THE SITE. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192295 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW UNSTABLE RAMP LESIONS OF THE MEDIAL MENISCUS IN ACL-DEFICIENT KNEE: COMPARING THE OUTCOMES OF OUTSIDE-IN VERSUS ALL-INSIDE SURGICAL REPAIR ¿ A RETROSPECTIVE STUDY, 4 PATIENTS HAD A RERUPTURE OF THE RL OF THE MENISCUS AFTER A MENISCUS ALL-INSIDE TECHNIQUE PROCEDURE USING A FAST FIX AND A BIOSURE ABSORBABLE SCREW. THE PATIENTS REQUIRED A PARTIAL MENISCECTOMY. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Rupture

  MAUDE report 16484807 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW UNSTABLE RAMP LESIONS OF THE MEDIAL MENISCUS IN ACL-DEFICIENT KNEE: COMPARING THE OUTCOMES OF OUTSIDE-IN VERSUS ALL-INSIDE SURGICAL REPAIR ¿ A RETROSPECTIVE STUDY, 3 PATIENTS HAD A RL SUTURE FAILURE AFTER A MENISCUS ALL-INSIDE TECHNIQUE PROCEDURE USING A FAST FIX AND A BIOSURE ABSORBABLE SCREW. THE PATIENTS REQUIRED A PARTIAL MEDIAL MENISCECTOMY. PATIENTS OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16484771 ↗
• InjuryAug 30, 2021Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, 3 BIORCI SCREWS BROKE OFF WHEN THEY WERE INSERTED. THE PROCEDURE WAS PERFORMED UNDER TOURNIQUET. THE INTERVENTION WAS DELAYED. THE GRAFT WAS NOT ABLE TO BE FIXED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389390 ↗
• InjuryJul 18, 2020Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SURGERY THE BIORCI WAS FOUND TO BE BROKEN WHEN IT WAS BEING INSERTED INTO THE PATIENT'S BODY. SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE WITH NO SIGNIFICANT DELAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10293080 ↗
• InjuryJun 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CL RECONSTRUCTION SURGERY TWO SCREWS WERE FRACTURED WHEN SCREW IN, ALL PIECES WERE REMOVED AND NO ADDITIONAL BONE HOLES WAS PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE, AND A DELAY GREATER THAN 30MIN WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10125438 ↗
• InjuryJun 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CL RECONSTRUCTION SURGERY THE SCREW FRACTURED WHEN SCREW IN, ALL PIECES WERE REMOVED AND NO ADDITIONAL BONE HOLES WERE PERFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A BACKUP DEVICE, NO SIGNIFICANT DELAY 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 10125335 ↗
• MalfunctionDec 12, 2018Break

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE WHEN TIGHTENING THE SCREW IN THE FEMUR THE SAME BROKE AND HAD TO BE REPLACED. NO BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8155824 ↗
• MalfunctionAug 27, 2018Break; Material Fragmentation; Physical Resistance/Sticking

  IT WAS REPORTED THAT SURGEON REQUESTED AND OPENED 7X25 WITH 8MM HEAD BIORCI-HA SCREW FOR FEMUR, AS PER RCI TECHNIQUE. HE DID NOT USED A TAP AND USED AN APPROPRIATE BIORCI SCREWDRIVER, WHEN THE SCREW WAS BEING ADVANCED INTO FEMUR SURGEON NOTED DIFFICULTY AND SCREW BROKE INTO PIECES. SCREW REMNANTS WERE RECOVERED AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7817156 ↗
• MalfunctionAug 27, 2018Crack

  IT WAS REPORTED SCREW CRACKED WHILE BEING ADVANCED INTO FEMORAL TUNNEL. SCREW RECOVERED AND SET ASIDE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7817099 ↗
• MalfunctionJul 10, 2018Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE SCREW SPLIT LENGTHWAYS DURING INSERTION. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7674265 ↗
• MalfunctionSep 25, 2017Break

  IT WAS CONFIRMED ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6890094 ↗