BIORCI 7207681Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 03596010460004), received between Aug 22, 2017 and May 1, 2026 — classified as 17 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (36 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC ACL RECONSTRUCTION PROCEDURE, THE BIORCI-HA SCREW GOT BROKE WHILE INSERTING INTO THE TIBIAL TUNNEL. THE BROKEN PARTS WERE REMOVED USING ARTERY, FORCEPS & SUCTION. THE PROCEDURE WAS RESUMED WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT ON THE ORIGINALLY DRILLED BONE HOLE, LEAVING NO VOID IN THE PATIENT. PATIENT IS SAFE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062185 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, AFTER THE INSERTION SITE WAS PREPARED WITH AN 8 MM CANNULATED DRILL, TUNNEL SIZE OF 8 MM, AND ALL DEBRIS WERE CLEARED, A BIORCI-HA SCREW WAS INTRODUCED WITH THE APPROPRIATE SCREWDRIVER BUT GOT BROKEN DURING INSERTION. ALL BROKEN PIECES WERE REMOVED USING ARTERY FORCEPS AND SUCTION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP, IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH STATUS IS SAFE. THE SURGEON WAS SATISFIED WITH THE SURGICAL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177516 ↗
• MalfunctionAug 8, 2025Break; Break

  IT WAS REPORTED THAT THE BIORCI-HA SCREW BROKE WHILE PUTTING IT ON THE TIBIAL SIDE. ALL THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING GRASPERS. THE PROCEDURE WAS COMPLETED USING A SMITH AND NEPHEW BACK UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754138 ↗
• MalfunctionMar 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A LEFT ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, WHEN THE BIORCI-HA WAS BEING IMPLANTED, IT FRACTURED. THE BROKEN PARTS WERE REMOVED FROM THE PATIENT WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND A SMITH AND NEPHEW BACK UP DEVICE ON THE ORIGINALLY DRILLED HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574399 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIORCI-HA TIP BROKE WHILE SCREWING INTO THE BONE. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT'S BONE WITH THE HELP OF A GRASPER. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664793 ↗
• MalfunctionAug 27, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI THREADS BROKE WHILE SCREWING IN THE TIBIAL TUNNEL GIVING LOOSE FIXATION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081770 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHILE TIGHTENING THE BIORCI SCREW IN THE TIBIAL TUNNEL, IT BROKE. THE TUNNEL WAS PREPARED WITH A 9MM TIBIAL DRILL AND WAS CLEARED OF ALL DEBRIS. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH THE HELP OF A GRASPER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552680 ↗
• MalfunctionMay 19, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE BIORCI ANCHOR WAS IMPLANTED AND REMOVED DUE TO A REPORTED MANUFACTURING DEFECT. 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 16965801 ↗
• InjuryFeb 8, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI SCREW BROKE WHILE SCREWING IN TO THE BONE. BROKEN PIECES WERE REMOVED SUCCESSFULLY WITH THE HELP OF GRASPER. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330332 ↗
• InjuryJan 31, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI SCREW IMPLANT BROKE DURING DEPLOYMENT. NON-SIGNIFICANT DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274778 ↗
• InjuryJan 31, 2023Break; Break

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272429 ↗
• InjuryDec 22, 2022Break; Break

  IT WAS REPORTED THAT DURING A TIBIAL FIXATION, THE BIORCI-HA SCREW BROKE DOWN. NON-SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035604 ↗
• InjuryOct 7, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE BIORCI SCREW BROKE, THE BROKEN PIECES WERE SUCCESSFULLY REMOVED BY TWEEZERS. NO SIGNIFICANT DELAY WAS REPORTED, AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15565037 ↗
• InjurySep 23, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A LIGAMENT REPAIR SURGERY, A BIORCI-HA´S SCREW THREADS WERE DEFORMED/ BROKEN AND THAT THE ANCHOR WAS SLIPPERY AND COULD NOT BE SCREWED IN AT ALL. SURGERY RESUMED AFTER A NON-SIGNIFICANT DELAY WITH A BACK-UP DEVICE, USED IN THE ORIGINALLY DRILLED BONE, THEREFORE NO VOIDS WERE LEFT IN THE PATIENT, WHOSE CURRENT HEALTH STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15470650 ↗
• InjurySep 8, 2022Break; Break

  IT WAS REPORTED THAT BEFORE AN ACL RECONSTRUCTION SURGERY, ONCE OPENED THE CARTON, IT WAS FOUND THE BIORCI SCREW BROKE. THERE WAS A BACK-UP DEVICE AVAILABLE AND A NON-SIGNIFICANT SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382328 ↗
• InjurySep 6, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PLASTY PROCEDURE, WHEN PLACING THE BIORCI HA SCREW AND GIVING IT THE FIRST TURN, IT BROKE AT THE TIP. ALL THE PIECES REMOVED WITH TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15365640 ↗
• InjuryJul 11, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI SCREW TIP GOT BROKEN WHILE SCREWING IN, ALL BROKEN PIECES WERE REMOVED FROM THE BONE WITH THE HELP OF A GRASPER. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14983448 ↗
• InjuryJun 22, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, THE BIORCI-HA SCREW BROKE WHILE TIGHTENING IT AT THE 9 MM TIBIAL TUNNEL. THE PROCEDURE WAS COMPLETED WITHOUT A DELAY USING A BACK-UP DEVICE. ALL PIECES WERE REMOVED USING TWEEZERS. PATIENT STATUS IS GOOD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14779288 ↗
• InjuryMay 9, 2022Break; Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14341963 ↗
• InjuryMar 23, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, THE TIP OF THE 'BIORCI' GOT BROKEN DURING DEPLOYMENT. ALL THE BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13865821 ↗
• InjuryFeb 24, 2022Break; Break

  IT WAS REPORTED THAT DURING USE IN AN ACLR PROCEDURE, THE SCREW BIORCI-HA ANCHOR BROKE DOWN WHILE INSERTING AT THE TIP OF THE TIBIA. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13596282 ↗
• InjuryAug 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE BIORCI SCREW BROKE DURING INSERTION INTO TIBIA. ALL THE BROKEN PIECES WERE RETRIEVED USING TWEEZERS AND NO ADDITIONAL BONE HOLE WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND NO SIGNIFICANT DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322443 ↗
• InjuryJun 28, 2021Break; Break

  IT WAS REPORTED THAT, DURING PROCEDURE, THE BIORCI SCREW BROKE WHEN DEPLOYING. IT IS UNKNOWN IF THERE WAS A BACKUP DEVICE AVAILABLE. NO DELAY NOR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12075104 ↗
• InjuryMay 11, 2021Break; Break

  IT WAS REPORTED THAT THE SCREW TIP OF THE BIORCI-HA BROKE WHILE IT WAS SCREWING IN. THE PIECES WERE REMOVED FROM THE PATIENT BY USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE IMPLANTED IN THE SAME BONE HOLE. NO SIGNIFICANT DELAY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809581 ↗
• MalfunctionJan 27, 2021Break; Break

  IT WAS REPORTED THAT DURING ACL RECONSTRUCTION, WHEN THE SCREW BOX WAS OPENED, THE SCREW WAS FOUND BROKEN. BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES WERE REPORTED. 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 11239849 ↗