INTRAFIX 254681Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886705013623), received between Jul 2, 2018 and Jul 22, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

5 other recalls cover devices cleared under the same FDA submission (K063577, K150209); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED BY THE AFFILIATE DURING A PRIMARY ACL RECONSTRUCTION, DEVICE WAS OPENED, AND BOX WAS EMPTY. OPENED A SECOND (DIFFERENT LOT NUMBER) AND SHEATH WOULDN'T DEPLOY (UNABLE TO INSERT INTO PATIENT). OPENED A THIRD TO COMPLETE CASE. 15 MINUTE DELAY. NO AE TO PATIENT.

  Patient problems: Not Applicable

  MAUDE report 8811494 ↗
• MalfunctionJan 21, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SCREW IN THE CUSTOMER'S FEMORAL INTRAFIX SHEATH & SCREW SYSTEM 7.5MM CRACKED AND FRACTURED DURING INSERTION PARALLEL TO THE SCREW. THE SALES REP STATED THAT THE SURGEON REMOVED THE SCREW WITH NO FURTHER ISSUES AND THAT NO DEBRIS WAS LEFT IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH A SMALLER SIZE 6 HARD BONE SCREW USING THE SAME SHEATH AND BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THAT THE PATIENT'S BONE QUALITY WAS HARD BONE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE FACILITY. 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 8264963 ↗
• MalfunctionAug 3, 2018Crack; Crack

  IT WAS REPORTED DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE THE INTRAFIX FEMORAL SHEATH & SCREW SYSTEM, 7.5 MM DEVICE CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7748166 ↗
• MalfunctionJul 31, 2018Material Rupture; Material Rupture

  IT WAS REPORTED BY THE AFFILIATE IN VIETNAM THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE INTRAFIX FEMORAL SHEATH & SCREW SYSTEM, 7.5 MM DEVICE RUPTURED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE. IT WAS NOT REPORTED IF THERE WERE ANY 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 7735869 ↗
• MalfunctionJul 13, 2018Break; Break

  THE SALES REP REPORTED ONE OF HIS INTRAFIX 7.5MM FEMORAL SCREWS BROKE UPON INSERTION INTO THE SHEATH DURING AN ACL PROCEDURE. HE STATED THE DEVICE STARTED TO CRACK AS THE SURGEON INSERTED THE DEVICE AND CONTINUED ANYWAYS AND THEN THE SCREW BROKE IN TWO PIECES. THE SURGEON REMOVED ALL FRAGMENTS OF THE SCREW BUT KEPT THE SHEATH IN THE PATIENT THEN INSERTED A NEW SCREW TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE DEVICE WAS ALREADY DISCARDED BY THE CUSTOMER. THE SALES REP STATED THIS WAS A (B)(6) FEMALE WITH HARD BONE AND BELIEVES THE SURGEON SHOULD HAVE USED A DIFFERENT TYPE OF SCREW FOR THE TYPE OF BONE. NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7687232 ↗
• MalfunctionJul 2, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT DURING THE SURGERY, PRODUCT WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7654133 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063577, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726