BIORCI 7207560Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010426222), received between Aug 31, 2017 and Oct 24, 2023 — classified as 8 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIORCI SCREW BROKE WHILE INSERTING INTO THE PATIENT. 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 17998199 ↗
• InjuryFeb 20, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE SCREW TIP OF THE BIORCI GOT BROKEN WHILE SCREWING INTO THE BONE. THE BROKEN PIECES WERE REMOVED SUCCESSFULLY WITH THE HELP OF A GRASPER. 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 16404419 ↗
• InjuryFeb 22, 2022Break; Break

  IT WAS REPORTED THAT DURING ACL PROCEDURE, INSIDE THE PATIENT, WHEN THE SCR BIORCI 8X25MM STRL BX 1 WAS USED ON THE TIBIAL SIDE, IT BROKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATION WERE REPORTED. RESULTS OF INVESTIGATION HAVE CONCLUDED THAT THIS UNIT HAD THE DISTAL END OF THE SCREW FRACTURED AND WITH DEBRIS IN THE THREADS, WHICH MAKES IT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13574980 ↗
• InjuryJun 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE BIO-RCI SCREW BROKE. A SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES WAS REPORTED. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092118 ↗
• InjuryJun 29, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, THE SCREW BROKE. THE SCREW WAS REMOVED BY THE HELP OF TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. NO SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12088949 ↗
• InjuryJun 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE BIORCI SCREW BROKE OFF. THERE WAS A BACKUP DEVICE AVAILABLE. NO SIGNIFICANT DELAY AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12071393 ↗
• InjuryMar 27, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, INSIDE THE PATIENT WITH THE SCR BIORCI 8X25MM STRL BX 1, THE SCREW STARTED DISINTEGRATE AND SOME PIECES WERE LEFT AT THE TIBIAL TUNNEL. THE SCREW WAS REMOVED AND THE TIBIAL TUNNEL WAS WASHED. THE PROCEDURE WAS FINISHED A SMITH AND NEPHEW BACK UP DEVICE. NO SURGICAL DELAY. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11580114 ↗
• InjuryOct 15, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT, THE PATIENT HAD THE FIRST SURGERY ON (B)(6) 2017, IN WHICH A "BIORCI SCREW (8X25MM)" WAS IMPLANTED IN HIM. HOWEVER, THE PATIENT CONSULTED ON (B)(6) 2020 FOR DISCOMFORT IN THE IMPLANT INSERTION AREA (TIBIA). SIGNS OF ULCERATION AND EXTRUSION OF THE IMPLANT WERE EVIDENT, AND ACCORDING TO THE SPECIALIST, THE ISSUE WAS ATTRIBUTED TO THE IMPLANT. SINCE THIS IS A BIO-ABSORBABLE SCREW, THE SPECIALIST DID NOT UNDERSTAND WHY APPROXIMATELY 33 MONTHS AFTER THE INITIAL IMPLANTATION, THIS HAS NOT YET COMPLETED ITS BIODEGRADATION. AS A RESULT OF THE ULCERATION, THE PATIENT WENT INTO A SECOND SURGERY, IN WHICH DURING THE PROCEDURE, THE INTACT AND COMPLETE SCREW WAS RETRIEVED, BUT IN THE PROCESS OF CLEANING THE IMPLANT TO LOWER ITS BIO-BURDEN, IT WAS NOTICED TO BE FRAGMENTED INTO SEVERAL PARTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE EVOLUTION OF THE PATIENT CONDITION IS SATISFACTORY. NO COMPLICATIONS WERE REPORTED IN THE SURGICAL ACT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10687309 ↗
• MalfunctionSep 16, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT DURING ACL SURGERY THE BIORCI'S SECONDARY PACKAGE/BOX DIDN´T CONTAIN THE DEVICE INSIDE, THE PACKAGING SHOWS EVIDENCE OF HAVING SUFFERED RUPTURE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACKUP 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 10544613 ↗
• InjuryAug 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, AFTER PASSING THE ALLOGRAFT THROUGH THE TUNNELS, THE MEDICAL STAFF PROCEEDED TO FIX THE GRAFT TO THE FEMUR WITH AN "8 X 25 MM BIORCI SCREW". HOWEVER, IT WAS NOT ACHIEVED BECAUSE WHEN TRYING TO FIX THE SCREW TO THE CORTEX, IT WAS NOTED THAT THE SCREWDRIVER ROTATED ON THE SAME AXIS OF THE SCREW BUT WITHOUT THE DESIRED PURPOSE. ANOTHER ATTEMPT WAS MADE TO REPLACE THE SCREW WITHOUT SUCCESS; THUS THE SCREW WAS REMOVED FROM THE PATIENT WITH A CLAMP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A 9 X 25 MM BIORCI SCREW INTO THE SAME BONE HOLE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10428806 ↗
• MalfunctionJan 28, 2019Break

  IT WAS REPORTED THAT, DURING AN UNKNOWN SURGERY, THE SCREW BROKE WHILE INSERTED. THE PROCEDURE WAS COMPLETED WITH LESS THAN 30 MINUTES DELAY USING OTHER SCREW (9X25 MM). NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8283619 ↗
• MalfunctionSep 19, 2018Break

  IT WAS REPORTED THAT THE SCREW TIP BROKE DURING INSERTION INTO TIBIAL TUNNEL. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889958 ↗
• MalfunctionAug 22, 2018Break

  IT WAS REPORTED THAT THE DISTAL PART OF THE SCREW WAS BROKE OFF INSIDE A PATIENT. ALL THE PARTS WERE REMOVED COMPLETELY FROM THE PATIENT. NO DELAY WAS REPORTED AND A BACKUP WAS AVAILABLE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7806171 ↗
• MalfunctionAug 8, 2018Break

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE SCREW WAS PLACED, THIS BROKE. THE SCREW WAS NOT COMPLETELY PLACED WHEN IT BROKE. THE DAMAGE PART WAS REMOVED COMPLETELY AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER OF THE SAME SMITH & NEPHEW DEVICE. NO DAMAGE TO THE PATIENT DUE TO THE INCIDENT THAT 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 7765285 ↗
• MalfunctionMay 19, 2018Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7528507 ↗
• MalfunctionJan 16, 2018Break

  IT WAS REPORTED THAT THE SCREW TIP BROKE WHILE IT WAS BEING PLACED. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7197231 ↗
• MalfunctionOct 31, 2017Break

  IT WAS REPORTED THAT FRONT-END OF BIORCI SCREW BROKE DURING SURGERY. FINALLY, A BACKUP DEVICE WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6991934 ↗
• MalfunctionSep 25, 2017Break

  IT WAS REPORTED BY CUSTOMER AT (B)(6) A BROKEN DEVICE DURING SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6892092 ↗
• MalfunctionAug 31, 2017Break

  IT WAS REPORTED THAT THE SCREW BROKE DURING INSERTION. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE FOLLOWING A SHORT DELAY OF LESS THAN 30 MINUTES. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6836624 ↗
• MalfunctionAug 31, 2017Break

  IT WAS REPORTED THAT THE SCREW BROKE DURING INSERTION. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE FOLLOWING A SHORT DELAY OF LESS THAN 30 MINUTES. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6836359 ↗