INTRAFIX 254836Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886705026296), received between Jul 3, 2018 and Apr 4, 2023 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 4, 2023Material Deformation; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HEX DRIVER DEVICE WAS TORQUED/TWISTED UPON INSERTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DRIVER WAS DEFORMED AT THE DISTAL PART, ACCORDING TO THE REPORT, THE SCREW WAS FULLY INSERTED AND IMPLANTS WERE COMPLETED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674524 ↗
• MalfunctionMar 10, 2023Device Contamination with Body Fluid; Device-Device Incompatibility; Device Contamination with Body Fluid; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE HEX DRIVER DEVICE DID NOT ALLOW THE 1.1MM GUIDE WIRE TO PASS. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT BIOLOGICAL MATTER COULD BE OBSERVED ON THE DEVICE. IT WAS REPORTED THAT THE DEVICE WAS USED WITHOUT THE 1.1MM GUIDE WIRE TO COMPLETE THE PROCEDURE WITH A DELAY OF TWO MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521972 ↗
• MalfunctionMay 15, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE RATCHET HANDLE DID NOT WORK PROPERLY AS THE RATCHET FUNCTION IS NOT WORKING ANYMORE. THE MANUAL FUNCTION HAD TO BE USED. IT WAS NOTICED AS WELL THAT THE TIP OF THE HEX DRIVER WAS TWISTED. SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THESE DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10062950 ↗
• MalfunctionMar 17, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT AFTER AN ACL PROCEDURE IT WAS NOTICED THAT THE CANNULA OF TWO HEX DRIVERS WERE OCCLUDED BY TISSUE AND CANNOT BE REMOVED. THE DEVICES WERE DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9844000 ↗
• MalfunctionMar 17, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT AFTER AN ACL PROCEDURE IT WAS NOTICED THAT THE CANNULA OF TWO HEX DRIVERS WERE OCCLUDED BY TISSUE AND CANNOT BE REMOVED. THE DEVICES WERE DISCARDED BY THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9843719 ↗
• MalfunctionSep 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT FOLLOWING AN ACL RECONSTRUCTION PROCEDURE DURING STERILIZATION IT WAS NOTICED THAT THE SALES REP'S INTRAFIX HEX DRIVER CANNULA WAS BENT. THE SALES REP DID NOT KNOW HOW THE DEVICE BENT. THE CASE WAS COMPLETED WITH A MILAGRO DRIVER WITH NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126114 ↗
• MalfunctionSep 26, 2019Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANT CRUCIATE LIGAMENT (ACL) RECONSTRUCTION PROCEDURE THE SALES REP'S INTRAFIX HEX DRIVER CANNULA WAS BENT. THE SALES REP DID NOT KNOW HOW THE DEVICE BENT. THE CASE WAS COMPLETED WITH A MILAGRO DRIVER WITH NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126079 ↗
• MalfunctionSep 25, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S INTRAFIX ADVANCE MODULAR HEX DRIVER BENT AT THE TIP WHILE TRYING TO INSERT THE SCREW. THE SALES REP STATED THAT IT LIKELY BENT FROM TORQUE. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT FOR THE CASE AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119326 ↗
• MalfunctionMay 14, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT FOLLOWING AN ACL RECONSTRUCTION PROCEDURE DURING STERILIZATION, THE CUSTOMER'S INTRAFIX HEX DRIVER HAD BONE STUCK IN THE CANNULA. THE SALES REP STATED THE BONE GOT STUCK IN THE DEVICE DURING THIS CASE. THE CASE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE THE LOT NUMBER OR ANY ADDITIONAL INFORMATION. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609522 ↗
• MalfunctionDec 19, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS IS REPORT 9 OF 9 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT PRIOR TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE DURING STERILIZATION, THE SALES REP'S INTRAFIX SMALL TRIAL, INTRAFIX LARGE TRIAL, INTRAFIX EXTRA LARGE TRIAL, INTRAFIX SMALL 23MM SHEATH INSERTER, INTRAFIX LARGE 23MM SHEATH INSERTER, INTRAFIX SMALL 30MM SHEATH INSERTER, INTRAFIX LARGE 30MM SHEATH INSERTER, INTRAFIX EXTRA LARGE 30MM SHEATH INSERTER, AND INTRAFIX HEX DRIVER ALL HAD BLOOD RESIDUE IN THE CANNULATED PORTIONS OF THE DEVICES. THE SALES REP STATED THAT THE FACILITY ATTEMPTED TO STERILIZE THE DEVICES THREE TIMES AND THE DEVICES COULD NOT BE CLEANED. THE CASE WAS COMPLETED WITH ANOTHER SET WITH NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR THE DEVICES. THE DEVICES ARE BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182074 ↗
• InjuryJul 3, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE WHEN INSERTING A 10X30MM SCREW THE TIP OF THEIR INTRAFIX ADVANCE MODULAR HEX DRIVER BROKE OFF IN THE HEAD OF THE SCREW ON THE LAST TURN. THE TIP WAS UNABLE TO BE RETRIEVED DUE TO IT BEING LODGED TIGHT WITHIN THE SCREW. THE SALES REP STATED THAT THE SURGEON WAS FINE WITH IT HAS HE STATED IT WOULD NOT GO ANYWHERE. THE PROCEDURE HAD BEEN COMPLETED WITH THE DEVICE WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE OTHER PART OF THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7658516 ↗