BIORCI 7207557Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010426208), received between Apr 17, 2018 and Aug 30, 2021 — classified as 2 injuries, 8 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 12389406 ↗
• InjuryOct 1, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION TECHNIQUE, THE BIORCI SCREW (7 MM X 25 MM) BROKE WHEN IT WAS BEING INSERTED INTO THE HOLE. ALL PIECES WERE REMOVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10618135 ↗
• MalfunctionNov 10, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE 7X25 MM BIORCI SCREW BROKE WHEN INSERTED INTO THE FEMORAL TUNNEL. ALL PIECES WERE RETRIEVED FROM THE PATIENT, BUT IT IS UNKNOWN HOW. AFTER REMOVAL, ANOTHER SCREW OF THE SAME DIAMETER WAS USED IN THE SAME BONE HOLE. SURGERY WAS DELAYED FOR LESS THAN 30 MIN. THE PATIENT WAS NOT HARMED. 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 9302717 ↗
• MalfunctionFeb 22, 2019Break; Crack

  IT WAS REPORTED THAT DURING FEMORAL FIXATION, THE SCREW WAS TIGHTENING AND THEN CRACKED AND SHATTERED. THERE WAS NO CONSIDERABLE DELAY IN THERAPY AND IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8363713 ↗
• MalfunctionNov 1, 2018Break

  IT WAS REPORTED THAT THE SCREW WAS BROKEN INSIDE THE TUNNEL. PIECES WERE REMOVED FROM PATIENT. MINIMAL DELAY WAS REPORTED AND BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8028675 ↗
• MalfunctionOct 10, 2018Break

  IT WAS REPORTED THAT THE SCREW TIP BROKE AFTER INTRODUCING INTO FEMORAL TUNNEL (FOLLOWING PRE-DRILLING). ALL PIECES WERE REMOVED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH O SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7953768 ↗
• MalfunctionAug 27, 2018Break; Failure to Advance

  IT WAS REPORTED THAT DURING A RECONSTRUCTION OF ANTERIOR CRUCIATE LIGAMENT, AT THE END OF THE PROCEDURE, JUST AT THE MOMENT OF FIXING THE GRAFT IN THE FEMORAL TUNNEL, AN INTERFERENCE SCREW (BIORCI 7 * 25, 8 MM HEAD) WAS USED. THIS WAS BEING SCREWED PROPERLY, BUT AT THE END OF THE PROCESS, THE SCREWDRIVER WAS ROLLED INSIDE THE HEAD'S SCREW, AND THIS DID NOT ADVANCE MORE FROM THAT SITE. SURGEON TRIED TO RETURN IT BUT THIS WAS NOT POSSIBLE, SCREWDRIVER WAS REMOVED, AND IT WAS NOTICED THAT THE SCREW WAS BROKEN AND THAT IT WAS NOT POSSIBLE TO MOVE IT FORWARD OR BACK. DUE TO THIS, THE REMAINING SCREW HEAD HAD TO BE BROKEN TO REMOVE THE FRAGMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7820172 ↗
• MalfunctionAug 14, 2018Break; Material Fragmentation

  IT WAS REPORTED THAT DURING THE PROCESS OF SCREWING THIS DEVICE, IT LOSES STRENGTH. IT WAS DECIDED TO BACK OFF THE SCREW OF THE TUNNEL, AND THEN, WE NOTICED THAT IT WAS BROKEN IN HALF, A DISTAL PART OF THE SCREW WAS INSIDE THE PATIENT AND ALL PARTS WEREREMOVED FROM PATIENT. NO PATIENT INJURIES WERE REPORTED AND A SMITH AND NEPHEW BACKUP WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7781971 ↗
• MalfunctionJul 11, 2018Break

  IT WAS REPORTED THAT AT THE MOMENT OF FIXING THE GRAFT (HAMSTRING) TO THE PATIENT, A 7 X 25 MM BIORCI SCREW WITH AN 8 MM HEAD WAS USED, THIS BEGAN TO FIT PERFECTLY INTO THE TUNNEL, BUT THE DEVICE LOST STRENGTH DURING THE PROCESS OF SCREWING. IT WAS DECIDED TO GET BACK THE SCREW OF THE TUNNEL, AND IT WAS BROKEN IN HALF, THE DISTAL PART WAS INSIDE THE PATIENT AND IT WAS ONLY POSSIBLE TO EXTRACT THE PROXIMAL PART (SCREW HEAD). FOR THIS REASON, IT WAS NOT POSSIBLE TO MAKE ANY OTHER TYPE OF FIXATION SINCE THE TIP OF THE SCREW WAS INSIDE THE TUNNEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679746 ↗
• MalfunctionApr 17, 2018Break

  IT WAS REPORTED THAT THE SCREW WAS BROKEN GIVING THE THIRD ROUND. IN ORDER TO REMOVE THE PROXIMAL PART OF THE SCREW, A KELLY CLAMP WAS USED. WE USED A SHAVER IN ORDER TO REMOVE THE REST OF FRAGMENTS. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED. A BIORCI 8X25 WAS USED TO FINISH THEPROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7436993 ↗