INTRAFIX 254684Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705013654), received between Jul 16, 2018 and May 8, 2019 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE AFTER DRILLING THE FEMORAL TUNNEL, THE SCREW OF THE FEMORAL INTRAFIX SYSTEM WAS INSERTED INTO THE PATIENT AND CAUGHT THE OUTER EDGE OF THE SHEATH AND THE SHEATH CRUMBLED. THE SALES REP STATED THE SCREW AND THE SHEATH WERE REMOVED WITH NO DEBRIS LEFT BEHIND. THE CASE WAS COMPLETED WITH ANOTHER LIKE-IMPLANT IN THE SAME BONE HOLE WITH NO PATIENT HARM OR DELAY. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE IMPLANT WAS DISCARDED BY THE CUSTOMER. 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 8591036 ↗
• MalfunctionJan 15, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SHEATH OF THE CUSTOMER'S INTRAFIX SHEATH AND SCREW SYSTEM 7MM BECAME DAMAGED WHEN THE SCREW WAS BEING INSERTED INTO IT. THE SURGEON REMOVED THE SCREW AND BROKEN SHEATH LEAVING NOTHING IN THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SAME TYPE SCREW AND SHEATH IN THE SAME BONE TUNNEL WITH NO PATIENT CONSEQUENCES OR DELAYS. 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 8247400 ↗
• MalfunctionOct 30, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE INTRAFIX FEMORAL SHEATH AND SCREW SYSTEM 9MM DEVICES BACKED OUT OF THE TUNNEL WHEN THE SCREW WAS BEING SCREWED IN. THEY THEN USED THE SALES REP'S INTRAFIX FEMORAL SHEATH AND SCREW SYSTEM 10MM, WHICH ALSO BACKED OUT OF THE TUNNEL WHILE THE SCREW WAS BEING SCREWED IN. EACH DEVICE WAS REMOVED FROM THE PATIENT WITH NO DEBRIS LEFT BEHIND. THE SALES REP STATED THAT THE PATIENT'S BONE QUALITY WAS NORMAL. THE CASE WAS COMPLETED WITH A RIGIDFIX DEVICE IN THE SAME BONE HOLE WITH NO PATIENT HARM OR DELAY. THE DEVICES WERE DISCARDED BY THE CUSTOMER. 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 8020524 ↗
• MalfunctionJul 16, 2018Break; Break

  THE SALES REP REPORTED THAT THE SCREW OF THE CUSTOMER'S INTRAFIX FEMORAL SHEATH AND SCREW SYSTEM, 9MM BROKE UPON INSERTION. THE SALES REP STATED THE SCREW WAS ABOUT 1/4 OF THE WAY IN THE BONE HOLE WHEN IT BROKE AT THAT POINT. THE SURGEON USED A DILATOR TO PREPARE THE HOLE AND WAS VERY FAMILIAR WITH THE PRODUCT HAVING USED IT SINCE IT'S INCEPTION. THE SURGEON COMPLETED THE PROCEDURE WITH THE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE ANCHOR WAS LEFT SECURELY IN THE BONE HOLE. THE SALES REP REPORTED THE BONE QUALITY WAS HARD. THE SALES REP WAS NOT PRESENT AND COULD NOT PROVIDE ANY MORE INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7689216 ↗

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-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-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-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-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-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