INTRAFIX 254680Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705013616), received between Jul 9, 2018 and Jul 11, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2022Crack; Crack

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022 IT WAS OBSERVED THAT THE FEMORAL INTRAFIX SYSTEM 7MM-7.5MM X 23MM, HARD DEVICE CRACKED WHEN INSERTED INTO THE SHEATH DUE TO HARD BONE. THE SCREW WAS RETRIEVED AND ANOTHER LIKE DEVICE WAS USED 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 14981962 ↗
• MalfunctionJul 13, 2018Break; Break

  THE SALES REP REPORTED THAT DURING AN ACL REPAIR THAT HIS INTRAFIX FEMORAL SCREW 8MM BROKE WHEN IT WAS 3/4 OF THE WAY INSERTED. THE SALES REP REPORTED THE TUNNEL SIZE WAS 8MM AND THE GRAFT WAS 7-7.5MM STATING IT AS A TIGHT FIT. THE SURGEON THEN USED THE DILATOR AND INSERTED THE SHEATH AND PROCEEDED TO INSERT THE SCREW WHEN IT BROKE IN HALF ABOUT 3/4 OF THE WAY IN. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SAME DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY THE SALES REP STATED THE PATIENT WAS (B)(6) FEMALE WITH HARD BONE QUALITY. THE SALES REP DID NOT KNOW THE PREEXISTING MEDICAL CONDITIONS, MEDICATIONS OR PREVIOUS SURGERIES. THE DEVICE WAS ALREADY DISCARDED BY THE FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7686896 ↗
• MalfunctionJul 9, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL REPAIR THAT THE PROXIMAL TIP OF THE SCREW OF HIS INTRAFIX FEMORAL SHEATH AND SCREW SET BROKE UPON INSERTION. THE SALES REP REPORTED THAT THE SURGEON WAS NOT OFF AXIS BUT WAS FORCEFUL WHEN IMPLANTING SCREW. THE SALES REP REPORTED THAT THE SURGEON PREPPED THE HOLE AND USED A DILATOR. THE SURGEON COMPLETELY REMOVED THE 1ST ANCHOR AND USED THE SAME BONE HOLE FOR THE 2ND ANCHOR. THE SURGEON AUGMENTED THE TUNNEL SIZE TO 10.5MM AND USED A BIGGER GRAFT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP STATED THE PATIENT WAS A (B)(6) MALE OF AVERAGE WEIGHT. THE BONE QUALITY WAS AVERAGE. THE SALES REP HAD NO KNOWLEDGE OF THE PATIENT'S MEDICATIONS OR PREEXISTING CONDITIONS. THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7671634 ↗

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-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-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-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-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
• 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