BIORCI 7207554Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 03596010426185), received between Aug 8, 2017 and Jan 3, 2022 — classified as 5 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE 'BIORCI' SCREW BROKE DURING ITS INSERTION INTO THE TIBIA. THE PROCEDURE WAS COMPLETED WITH A S+N BACKUP DEVICE. THERE WAS A NON-SIGNIFICANT DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13146196 ↗
• InjuryDec 22, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE SCREW OF THE BIORCI 7X25MM STRL BX 1, WAS FRACTURED. ALL PIECES WERE REMOVED USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE ORIGINAL DRILLED BONE HOLE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061973 ↗
• InjuryAug 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE BIORCI SCREW BROKE WHEN IT WAS INSERTED INTO THE FEMORAL TUNNEL. THE INDICATIONS FOR USE OF THE TUNNEL SIZE 8MM DIAMETER AND THE COMPLETE 7MM HOLE WERE PREVIOUSLY FOLLOWED. PARTS WERE REMOVED. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. NO SIGNIFICANT DELAY AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389287 ↗
• InjuryJun 30, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE BIORCI SCREW BROKE. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094754 ↗
• InjuryFeb 23, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY WHILE IMPLANTING THE BIORCI THE END OF THE TIP BROKE OFF. ALL THE BROKEN PIECES WERE REMOVED USING TWEEZERS AND FORCEPS. NO DELAY OR OTHER COMPLICATIONS WERE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. 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 11364490 ↗
• MalfunctionApr 3, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE SCREW BROKE WHILE IT WAS BEING INSERTED. 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 9925020 ↗
• MalfunctionFeb 4, 2020Material Separation; Material Separation

  IT WAS REPORTED ABOUT A 7X25MM BIORCI SCREW THAT, DURING A PROCEDURE, AFTER PERFORMING THE TUNNELS WITH THE DRILL IN THE FEMORAL PART FOR FIXING THE 9.5MM HTH GRAFT, AT THAT MOMENT WHEN THE SCREW WAS GOING THROUGH THE PASSING PIN, THIS ONE BROKE. ALL THE FRAGMENTS WERE REMOVED USING THE SAME SCREWDRIVER AND A KELLY CLAMP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SOFSILK SCREW BACK-UP DEVICE. NO PATIENT INJURIES 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 9665856 ↗
• MalfunctionJul 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION SURGERY, THE BIORCI SCREW BROKE AT THE FRONT END. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT BY USING TWEEZERS. A BACK-UP DEVICE WAS USED, IN THE SAME BONE HOLE, TO COMPLETE THE PROCEDURE. THE SURGERY WAS NOT SIGNIFICANTLY DELAYED. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8786748 ↗
• MalfunctionJun 20, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE WAS BROKEN. ALL PIECES WERE REMOVED WITH TWEEZERS. THE PROCESS WAS COMPLETED BY ENLARGING ONE SIZE OF THE HOLE AND SCREW SIZE WITH A BACKUP DEVICE. NO SIGNIFICANT DELAY OR PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8719340 ↗
• MalfunctionDec 5, 2018Break

  IT WAS REPORTED THAT, DURING THE SURGERY, THE SCREW BROKE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8134392 ↗
• MalfunctionOct 3, 2018Break

  IT WAS REPORTED THAT WHEN THE SCREW WAS PASSED THROUGH THE GUIDE, IT CAME OUT FROM THE TUNNEL, BECAUSE THIS WAS BROKEN, THE DOCTOR PROCEED TO REMOVE IT, AS THE WOUNDS WERE SMALL AND THE SCREW WAS NOT VERY WELL FIXED, THE SCREW WAS INSIDE THE KNEE PATIENT. DOCTOR HAD TO MAKE A LARGER INCISION TO REMOVE IT, IT WAS ALL REMOVED AND ANOTHER SCREW WAS PASSED. A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7930927 ↗
• MalfunctionSep 8, 2018Break

  IT WAS REPORTED THAT ISCHIOTIBIAL GRAFTS WERE TAKEN AND IT WAS PREPARED FOR SCREW-SCREW TECHNIQUE. GRAFT DIAMETER WAS TAKEN, WHICH WAS 8 MM, THEN THEY STARTED TO MAKE THE TUNNELS OF THE SAME DIAMETER. AFTER ASCENDING THE GRAFT TO ITS POSITION, THEY PROCEEDED TO FIX THIS, FIRST IN THE FEMUR; CONSTANT TRACTION OF THE GRAFT WAS DONE WITH THE SUTURES IN THE PROXIMAL AND DISTAL PART. THE CANNU-FLEX OF 1.5 WAS PLACED IN THE FEMUR, THROUGH WHICH THE SCREW 7X25 WAS PASSED, BUT BEFORE REACHING THE MIDDLE OF THE THREAD, IT WAS BROKEN IN ITS DISTAL THIRD. PART OF THE SCREW WAS REMOVED BUT THE REST WAS NOT POSSIBLE. SCREW OF THE SAME DIAMETER AND LENGTH WAS PASSED WITHOUT ANY INCONVENIENCE. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7858533 ↗
• MalfunctionAug 13, 2018Break; Noise, Audible

  IT WAS REPORTED THAT WHEN THE DOCTOR STARTED TO SCREW, IT WAS INTRODUCED NO MORE THAN 5 MILLIMETERS AND A STRONG SOUND WAS HEARD, IT WAS OBSERVED BY ARTHROSCOPY AND THE SCREW WAS BROKEN ALONG IN TWO, THE SCREW WAS REMOVED FROM THE PATIENT KNEE. ANOTHER SCREW, SAME LENGTH AND DIAMETER, WAS PASSED AND THIS WORKED PROPERLY. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7776283 ↗
• MalfunctionAug 12, 2018Break

  IT WAS REPORTED THAT AT THE TIME OF PLACING THE SCREW, THE TIP BROKE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME DEVICE. NO DAMAGE TO THE PATIENT WAS REPORTED SINCE THE PIECE WAS REMOVED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7775824 ↗
• MalfunctionAug 12, 2018Break

  IT WAS REPORTED THAT SCREW BROKE WHEN PUSHED TO THE POSTERIOR WALL OF THE FEMORAL. THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME DEVICE. NO DAMAGE TO THE PATIENT WAS REPORTED SINCE THE PIECE WAS REMOVED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7775815 ↗
• MalfunctionAug 8, 2018Break

  IT WAS REPORTED THAT AT THE TIME OF STARTING TO PLACE THE SCREW, THIS BROKE IN THE DISTAL PART. THE SCREW WAS PARTIALLY PLACED WHEN THE INCIDENT HAPPENED. THE DAMAGE PART WAS BROKE INSIDE THE PATIENT; HOWEVER, IT WAS REMOVED COMPLETELY AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME DEVICE. NO DAMAGE TO THE PATIENT WAS REPORTED SINCE THE PIECE WAS REMOVED WITHOUT PROBLEM. THE PATIENT´S HEALTH CONDITION IS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7765291 ↗
• MalfunctionAug 7, 2018Break

  IT WAS REPORTED THAT WHILE THE SCREW WAS BEING PLACED IT BROKE. DAMAGED SCREW WAS REMOVED AND A BACK-UP WAS USED TO COMPLETE THE PROCEDURE. NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7758612 ↗
• MalfunctionMay 29, 2018Fracture

  IT WAS REPORTED THAT DURING THE PLACING OF THE GRAFT TO THE PATIENT WITH THE BIORCI SCREW 7X25 IN THE FEMORAL TUNNEL, A CLICK WAS HEARD WHEN THE SCREW WAS IN CONTACT WITH THE BONE, WHEN TRYING TO REMOVE THE SCREW, THERE WAS EVIDENCE THAT IT WAS FRACTURED, LEAVING INTO THE PATIENT SOME FRAGMENTS DIFFICULT TO REMOVE. THE SCREW AND THE FRAGMENTS WERE REMOVED AND IT WAS REPLACED BY ANOTHER BIORCI DEVICE WITH NO SIGNIFICANT SURGICAL DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7549050 ↗
• MalfunctionNov 20, 2017Break; Use of Device Problem

  IT WAS REPORTED THAT THE SCREW BROKE WHILE TIGHTENING.

  Patient problems: No Information

  MAUDE report 7044783 ↗
• MalfunctionOct 10, 2017Break

  IT WAS REPORTED THAT THE BIORCI 7X25MM STRL BX 1 SCREW BROKE WHILE TIGHTENING. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6937676 ↗
• MalfunctionAug 8, 2017Break

  IT WAS REPORTED THAT THE SCREW BROKE DURING IMPLANTATION. ALL PIECES OF THE SCREW WERE REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH A SHORT DELAY REPORTED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6774124 ↗
• MalfunctionAug 8, 2017Break

  IT WAS REPORTED THAT THE SCREW BROKE DURING IMPLANTATION. ALL PIECES OF THE SCREW WERE REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH A SHORT DELAY REPORTED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6773845 ↗