INTRAFIX 254654Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705022403), received between Jul 13, 2018 and Jul 12, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K013572, K122123, K150209, K983560); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 10 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (DPS_JMP_2018_067) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX ® PEEK TAPERED SCREW 8-10MM X 30MM DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17309038 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (DPS_JMP_2018_067) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX ® PEEK TAPERED SCREW 8-10MM X 30MM DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14991230 ↗
• MalfunctionDec 21, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED BY THE SALES REP THAT FOREIGN BLACK MATTER WAS FOUND INSIDE THE STERILE PACKAGING OF INTRAFIX PEEK TP SCR 8-10MM X 30MM DEVICE. THE DEVICE WAS NOT USED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11045815 ↗
• InjuryMay 3, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT ON (B)(6) 2018, THE PATIENT UNDERWENT THE FIRST ACL RECONSTRUCTION PROCEDURE WITH THE INTRAFIX SHEATH AND SCREW. AFTER APPROXIMATELY FIVE MONTHS POST-OPT, THE PATIENT NOTICED REDNESS AND A PIN-HOLE OPENING AROUND THE PROCEDURE SITE. THE SALES REP STATED THAT THE SCREW WAS VISIBILITY PUSHING AGAINST THE SKIN. THE PATIENT WENT BACK FOR A REVISION PROCEDURE ON (B)(6) 2019 TO HAVE THE SHEATH AND THE SCREW REMOVED. THE SALES REP STATED THAT WHILE REMOVING THE IMPLANTS FROM THE PATIENT, THERE WAS NO INFECTION NOTICED. THE SALES REP STATED THAT NO REPLACEMENT IMPLANTS WERE INSERTED INTO THE PATIENT DURING THIS PROCEDURE. THE IMPLANTS WERE DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Code Available

  MAUDE report 8577894 ↗
• MalfunctionJan 29, 2019Difficult to Insert; Difficult to Insert

  THE SALES REP REPORTED VIA PHONE CALL THAT THE CUSTOMER'S INTRAFIX TIBIAL SHEATH 30MM AND INTRAFIX PEEK TAPER SCREW 8-10MM X 30MM FAILED DURING AN ACL PROCEDURE DUE TO THE SCREW BOTTOMING OUT WHILE USING THE SHEATH. SHEATH WOULD NOT GUIDE THE SCREW AND ALLOW IT TO BE PUT IN PLACE. THE CASE WAS COMPLETED USING ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THERE WAS A TWO MINUTE TIME DELAY TO GET THE OTHER DEVICES. THIS IS REPORT 2 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285876 ↗
• MalfunctionJan 11, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE INTRAFIX PEEK TP SCR 8-10MMX30MM SCREW DEVICE WHILE IN USE WITH THE INTRAFIX TIBIALSHEATH 30MM *EA DEVICE GOT ABOUT 2/3 OF THE WAY IN AND WOULD NOT ADVANCE ANY FURTHER AS THE SCREW WAS BEING INSERTED. ACCORDING TO THE REPORTER, THE SURGEON HAD A SIZE 9 TIBIAL TUNNEL AND OPENED A TIBIAL SHEATH AND AN 8-10 SCREW TO FIX THE TIBIAL SIDE OF THE ACL WITH. IT WAS FURTHER REPORTED THAT THE SUTURES WERE FASTENED TO THE TIE TENSIONER, THE TUNNEL WAS DILATED WITH THE INTRAFIX DILATOR, THE SHEATH WAS PLACED APPROPRIATELY, THEN WHEN THE SURGEON ATTEMPTED TO INSERT THE SCREW, THE EVENT OCCURRED. IT WAS REPORTED THAT THE SHEATH AND SCREW STARTED SPINNING AS ONE UNIT. IT WAS REPORTED THAT THE SHEATH AND 8-10 SCREW WERE REMOVED THEN THE GRAFT WAS CHECKED TO MAKE SURE NO DAMAGE WAS DONE AND IT WAS FINE. HE OPENED ANOTHER SHEATH AND A SMALLER SCREW AND THEY WENT IN PERFECTLY. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8241153 ↗
• MalfunctionJul 13, 2018Break; Break

  THE SALES REP REPORTED WHILE THE SURGEON WAS INSERTING ONE OF HIS INTRAFIX PEEK SCREWS INTO THE INTRAFIX TIBIAL SHEATH THAT WAS ALREADY INSERTED, A PORTION OF THE DISTAL TIP OF THE SCREW BROKE AND DAMAGED THE SHEATH INSIDE DURING AN ACL PROCEDURE. THE SURGEON REMOVED BOTH THE BROKEN SCREW AND ALL ITS FRAGMENTS AND THE SHEATH. HE THEN INSERTED A NEW SHEATH AND A NEW SCREW WITH NO ISSUES. THERE WERE NO PATIENT CONSEQUENCES AND A 5 MINUTE DELAY. BOTH DEVICES WERE DISCARDED ALREADY BY THE CUSTOMER. THE SALES REP WAS NO PRESENT BUT WAS ABLE TO PROVIDE THE FOLLOWING INFORMATION. THE SURGEON USED AN 8 AND A 1/2 TUNNEL, THE GRAFT WAS ALSO 8 AND A 1/2. IT WAS AN 8-10X 30 MM SIZE SCREW AND HE STATED THIS SURGEON DOES NOT USE A TENSIONER. HE WAS UNAWARE IF THE SHEATH WAS ANTIROTATION TAB PLACED AT THE 3 OR 9 O'CLOCK POSITION? IT WAS A (B)(6) MALE PATIENT WITH HARD BONE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51183.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7686546 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013572, K122123, K150209, K983560. One submission often covers many models, so check the product and lot details in each record.

• 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-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