BIORCI 7209017Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03596010460042), received between Nov 27, 2017 and May 18, 2026 — classified as 11 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, ONE (1) BIORCI SCREW BROKE WHILE INSERTION AT SITE. THE PROCEDURE WAS RESUMED, AFTER A NON SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT. ADDITIONAL ANESTHESIA WAS NOT REQUIRED AS CONSEQUENCE OF THE SURGICAL PROLONGATION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25210632 ↗
• MalfunctionMar 23, 2026Fracture

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, ONE (1) BIORCI-HA INTERFERENCE SCREW FRACTURED INTRAOPERATIVELY. THE FAILURE OCCURRED WHILE THE SCREW WAS BEING DRIVEN INTO THE BONE TUNNEL. THE SCREW SHEARED UNDER NORMAL INSERTION TORQUE WHEN IT WAS APPROXIMATELY 2/3 (TWO-THIRD) INSERTED. THE POSTERIOR 1/3 (THE PORTION CLOSEST TO THE DRIVER) BROKE OFF AND WAS OUTSIDE THE TUNNEL. HOWEVER, THE ANTERIOR 2/3 OF THE SCREW REMAINED DEEPLY LODGED AND SECURELY FIXED WITHIN THE BONE TUNNEL. THE SURGEON HAD TO UTILIZE A COMBINATION OF ARTHROSCOPIC GRASPERS AND A REVERSE SCREW TECHNIQUE (ENGAGING THE BROKEN FRAGMENT TO BACK-THREAD IT OUT) TO SUCCESSFULLY CLEAR THE TUNNEL. THE SURGEON SUCCESSFULLY RETRIEVED ALL FRAGMENTS OF THE FRACTURED BIO-COMPOSITE SCREW FROM THE BONE TUNNEL. THE TUNNEL WAS THOROUGHLY IRRIGATED AND INSPECTED TO CONFIRM NO DEBRIS OR MATERIAL REMNANTS WERE LEFT BEHIND. THE PROCEDURE WAS RESUMED, WITH A DELAY GREATER THAN 30 MIN, USING A SIMILAR S+N BACK-UP PRODUCT. NO ADDITIONAL ANESTHESIA WAS REQUIRED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24667490 ↗
• MalfunctionNov 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, IT WAS NOTICED THAT THE SCR BIORCI-HA 10X30 STERILE ANCHOR BROKE, WHEN THE SURGEON PUT IT IN THE PILOT HOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638188 ↗
• MalfunctionOct 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY, THE TIP OF THE BIORCI HA SCREW BROKE WHILE INSERTING. THE PROCEDURE WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, USING A SIMILAR S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334026 ↗
• MalfunctionDec 3, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI SCREW GOT BROKEN. SURGERY WAS COMPLETED USING A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833216 ↗
• MalfunctionOct 22, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI-HA SCREW BROKE WHILE DEPLOYED. 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 20505666 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIORCI-HA BROKE WHILE BEING INSERTED INTO THE BONE. 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 20147112 ↗
• MalfunctionJul 31, 2024Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BIORCI-HA SCREW BROKE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO SURGICAL DELAY, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19877155 ↗
• MalfunctionJul 8, 2024Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPIC PROCEDURE, THE BIORCI-HA SCREW BROKE WHILE INSERTING AT SITE. SURGERY WAS COMPLETED WITH A BACK-UP DEVICE INSTEAD. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697422 ↗
• MalfunctionJan 30, 2024Break; Break

  IT WAS REPORTED THAT DURING SET UP, THE BIORCI-HA SCREW GOT BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607764 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI SCREW GOT BROKEN WHILE TIGHTENING INSIDE THE TIBIA BONE. THE BROKEN SCREW WAS REMOVED THROUGH SUCTION. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647106 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHILE TIGHTENING THE BIORCI SCREW, THE TIP OF THE SCREW BROKE. THE TUNNEL WAS MADE OF 10MM USING A TIBIAL DRILL BIT. THE WHOLE SCREW WAS REMOVED WITH HELP OF GRASPER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINAL TUNNEL. NO VOID WAS LEFT IN THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552321 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW BIORCI-HA THREAD BROKE AND DILATED DURING INSERTION IN THE TIBIA. 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 17550905 ↗
• InjuryDec 13, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, THE TIP OF THE BIORCI SCREW BROKE WHILE SCREWING INTO THE TIBIA. THE TUNNEL SIZE WAS OF 10MM. THE BROKEN SCREW WAS REMOVED FROM THE PATIENT WITH THE HELP OF A DRIVER. SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY, USING A BACK-UP DEVICE INSTEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969176 ↗
• InjuryOct 20, 2022Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI ANCHOR DID NOT HOLD AND BROKE. THE TIBIAL BONE DRILLED HOLE WAS OF 10MM AND THE ANCHOR WAS REMOVED WITH DRIVER AND TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A BACK-UP DEVICE IN THE ORIGINAL DRILLED BONE HOLE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639995 ↗
• InjuryAug 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY, WHEN THE BIORCI SCREW WAS BEING PLACED, IT BROKE INTO PIECES. THE ISSUE WAS RESOLVED USING A BACK-UP DEVICE INSTEAD, HOWEVER IT IS UNKNOWN IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15242651 ↗
• InjuryMay 17, 2022Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE 'BIORCI' SCREW BROKE WHILE SCREWING, ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAY USING A BACK-UP DEVICE IN THE ORIGINALLY DRILLED BONE HOLE, NO VOID WAS LEFT IN PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14415558 ↗
• InjuryApr 27, 2022Break; Break

  IT WAS REPORTED THAT DURING A LCA RECONSTRUCTION, THE BIORCI ANCHOR BROKE DURING SCREWING. ALL THE PIECES WERE REMOVED FROM THE PATIENT BY TWEEZERS. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. THE ORIGINALLY DRILLED BONE HOLE WAS USED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14224731 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT DURING A ACL RECONSTRUCTION PROCEDURE, THE SCR BIORCI-HA 10X30 STERILE BROKE DURING DEPLOYMENT INTO THE TIBIA. THE PIECES WERE REMOVED WITH TWEEZERS. NO ADDITIONAL HOLE WAS REQUIRED. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. A DELAY OF LESS THAN 30 MINUTES WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11850089 ↗
• InjuryApr 15, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, INTERNAL TO THE PATIENT, THE SCREW BROKE. ALL PIECES WERE REMOVED USING A SCREW DRIVER. 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. 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 11676301 ↗
• InjuryApr 15, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING AN ACL REPAIR SURGERY, THE THREADS OF THE "10X30 BIORCI HA SCREW" WORE OFF WHILE INSERTING THE SCREW INTO THE TIBIA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE INTO THE SAME BONE HOLE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11673304 ↗
• InjuryFeb 1, 2021Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE BIORCI SCREW BROKE WHILE SCREWING IN. THE PROCEDURE WAS 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11262398 ↗
• InjuryAug 5, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION, WHILE TIGHTENING THE BIORCI-HA SCREW IN THE TIBIA, IT BROKE. ALL PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE IN THE SAME BONE HOLE. NO 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 Information

  MAUDE report 10369201 ↗
• InjuryJul 7, 2020Break; Break

  IT WAS REPORTED THAT WHILE INSERTING THE SCREW IN TIBIA, IT SUDDENLY BROKE. THERE WAS A DELAY SHORTER THAN 30 MINUTES AND THE PROBLEM WAS SOLVED USING A BACK UP DEVICE AND REMOVING THE PIECES WITH A CURETTE AND FORCEPS. NO ADDITIONAL BONE HOLES WERE REQUIRED PATIENT HARM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10242738 ↗
• MalfunctionOct 3, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE ANCHOR BROKE WHILE BEING INSERTED, BROKEN PIECES WERE REMOVED USING A MOSQUITO GRASPER. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE WITH NO SIGNIFICANT DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9150828 ↗