BioScrew HyperFlex C8006DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10845854041697), received between Jul 24, 2019 and Jan 16, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2025Material Fragmentation; Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE C8006D, GUIDEWIRE, NITINOL 14 IN, STERILE DEVICE WAS USED IN AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2024 AND POST-OPERATIVELY, ON (B)(6) 2024, THE DOCTOR ¿TOOK POST OP X-RAYS OF THE PATIENT AND REALIZED THAT ONE OF OUR GUIDE WIRES FOR OUR SCREWS IS STILL IN THE PATIENT, EMBEDDED IN THE AUTOGRAFT. WE ARE NOT POSITIVE IF IT IS THE GUIDEWIRE FROM THE 8820 ACL KIT (LOT 1422285) OR THE C8006D GUIDEWIRE (LOT 1183654), BOTH WERE OPENED IN THE CASE. THE PATIENT HAS NO PAIN OR ISSUES AT THE MOMENT THE WIRE WAS FOUND DURING A ROUTINE POST OP X-RAY. DR. IS GOING TO CONTINUE TO TAKE X-RAYS AT 3 AND 6 MONTHS TO SEE IF THERE IS ANY ISSUES BUT AS OF NOW, HE SEES NO NEED TO HAVE ANOTHER SURGERY AND REMOVE THE WIRE.¿. FURTHER ASSESSMENT FOUND "IT IS DEFINITELY A PIECE OF THE GUIDE WIRE ABOUT THE ENTIRE LENGTH OF THE ACL GRAFT. THE ENTIRE PIECE IS INTACT". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A RETAINED FOREIGN BODY, WHOSE DEVICE ORIGIN CANNOT BE CONFIRMED. THE 8820, ANATOMIC ACL DISPOSABLE KIT WILL BE LISTED AS A CONCOMITANT DEVICE, AND ALLEGATIONS AGAINST IT REPORTED SEPARATELY.

  Patient problems: Foreign Body In Patient

  MAUDE report 21167534 ↗
• MalfunctionApr 22, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT C8006D, BIOSCREW HYPERFLEX GUIDEWIRE NITINOL 14 IN STER WAS BEING USED DURING A HIP ARTHROSCOPY PROCEDURE ON APPROXIMATELY 27MAR24 DATE WHEN IT WAS REPORTED ¿THE NITINOL WIRE BROKE INSIDE THE PATIENT DURING HIP ARTHROSCOPY.¿. IT WAS ALSO REPORTED THAT ¿RECOVERING THE BROKEN PIECE OF NITINOL WIRE WITH DIFFICULTY. A NEW NITINOL WIRE WAS GIVEN TO CONTINUE THE HIP ARTHROSCOPY.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19158168 ↗
• InjuryJul 24, 2019Material Fragmentation; Material Fragmentation

  ON BEHALF OF THE CUSTOMER, THE CONMED REPRESENTATIVE REPORTED ISSUES WITH THE BIOSCREW HYPERFLEX GUIDEWIRE NITINOL 14 IN STERILE, ITEM # C8006D, LOT # 986788 THAT OCCURRED AT THE ORTHOPAEDIC & SPINE CENTER OF SOUTHERN COLORADO. IT WAS REPORTED THAT DURING AN ACL PROCEDURE ON (B)(6) 2019, THE BIOSCREW HYPERFLEX GUIDEWIRE BROKE OFF INTO THE PATIENT'S KNEE AFTER THE INTERFERENCE SCREW HAD BEEN ADVANCED. ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE TIBIAL TUNNEL WAS DRILLED USING CONSTANT DIAMETER REAMER, GUIDEWIRE WAS USED WITH GENESYS MATRYX INTERFERENCE SCREW ALONG WITH THE TRI-LOBE RATCHETING DRIVER. THE GENESYS MATRYX INTERFERENCE SCREW WAS COMPLETELY ADVANCED INTO PATIENT WHEN SURGEON TRIED TO REMOVE THE GUIDE WIRE. AT WHICH POINT, THE WIRE DID NOT COME OUT. IT WAS ESTIMATED THAT 1-2 INCHES OF THE 14-INCH GUIDEWIRE BROKE OFF INTO THE KNEE. THE SURGEON CONTINUED SEARCHING FOR THE WIRE IN THE JOINT AFTER IT HAD BROKEN. THE PHYSICIAN REMOVED AS MUCH OF THE WIRE IN THE JOINT AS POSSIBLE AND TRIMMED BACK THE GUIDE WIRE IN THE JOINT BACK UNTIL A SMALLER AMOUNT WAS RETAINED ON THE TIBIAL SIDE BEFORE CLOSING. THE PROCEDURE WAS COMPLETED WITH A 5-10MINUTE DELAY. THERE WAS NOTHING UN

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8823053 ↗