INTRAFIX 254601Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886705013074), received between May 21, 2018 and Jul 25, 2025 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

5 other recalls cover devices cleared under the same FDA submission (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER (B)(4) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX TIBIALSHEATH 30MM DEVICE, INTRAFIX TAPERSCR 8-10X30MM DEVICE AND TRUESPAN 0 DEGREE PEEK DEVICE FAILED AND THE PATIENT REQUIRED A RE-OPERATION OR REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. A COPY OF THIS REPORT IS TO THIS MEDWATCH REPORT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22610560 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 5 OF 10 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER (B)(4) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX TIBIALSHEATH 30MM DEVICE FAILED AND THE PATIENT REQUIRED A RE-OPERATION OR REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22579216 ↗
• 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 (B)(6) 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 30MM INTRAFIX TIBIAL SHEATH 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 14990001 ↗
• 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 TIBIALSHEATH 30MM *EA 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 11045804 ↗
• InjuryMay 3, 2019Migration 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 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 8577939 ↗
• MalfunctionJan 29, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED 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 1 OF 2.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285877 ↗
• MalfunctionJan 11, 2019Migration 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 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 HOSPIT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8241294 ↗
• MalfunctionSep 12, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL REPAIR THAT THE CUSTOMER INTRAFIX TIBIAL SHEATH BROKE WHEN THE SURGEON WAS INSERTING THE SCREW. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER SAME SIZE, SAME TYPE OF SHEATH IN THE SAME BONEHOLE. THE SALES REP REPORTED THE SURGEON REMOVED THE BROKEN PIECES LEAVING NO DEBRIS IN THE PATIENT'S JOINT SPACE. THE SALES REP REPORTED THE FAILURE WAS DUE TO THE USER'S TECHNIQUE. 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 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 7868498 ↗
• MalfunctionAug 27, 2018Break; Break

  CUSTOMER REPORTS PERFORATION OF COVER SHIELD, PROBABLY BECAUSE OF DAMAGE CANNULATED HEX DRIVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7817154 ↗
• MalfunctionAug 27, 2018Break; Break

  CUSTOMER REPORTS PERFORATION OF COVER SHIELD, PROBABLY BECAUSE OD DAMAGE CANNULATED HEX DRIVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7817136 ↗
• MalfunctionJul 23, 2018Crack; Crack

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT DURING AN ACL REPAIR THAT THE CUSTOMER'S INTRAFIX SCREW AND TWO OF THEIR INTRAFIX TIBIAL SHEATHS, 30MM, BROKE OR DEFORMED DURING INSERTION. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON PREPARED THE BONEHOLE, USED THE TRIAL, AND INSERTED THE FIRST SHEATH. WHEN HE INSERTED THE SCREW INTO THE SHEATH, THE SHEATH CRACKED IN HALF. THE SURGEON COMPLETELY REMOVED THE SCREW AND BROKEN SHEATH AND RE-TRIALED THE BONE HOLE. HE THEN INSERTED THE 2ND SHEATH AND UPON INSERTING THE ORIGINAL SCREW INTO THIS SHEATH IT DEFORMED AND APPEARED MELTED. THE SURGEON COMPLETELY REMOVED THE SHEATH AND THE SCREW A SECOND TIME. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER TYPE OF FIXATION WITH NO PATIENT CONSEQUENCES BUT WITH A 15 MINUTE DELAY. THE CUSTOMER DISCARDED ALL OF THE COMPLAINT DEVICES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7711398 ↗
• MalfunctionJul 23, 2018Crack; Crack

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT DURING AN ACL REPAIR THAT THE CUSTOMER'S INTRAFIX SCREW AND TWO OF THEIR INTRAFIX TIBIAL SHEATHS, 30MM, BROKE OR DEFORMED DURING INSERTION. THE SALES REPRESENTATIVE REPORTED THAT THE SURGEON PREPARED THE BONEHOLE, USED THE TRIAL, AND INSERTED THE FIRST SHEATH. WHEN HE INSERTED THE SCREW INTO THE SHEATH, THE SHEATH CRACKED IN HALF. THE SURGEON COMPLETELY REMOVED THE SCREW AND BROKEN SHEATH AND RE-TRIALED THE BONE HOLE. HE THEN INSERTED THE 2ND SHEATH AND UPON INSERTING THE ORIGINAL SCREW INTO THIS SHEATH IT DEFORMED AND APPEARED MELTED. THE SURGEON COMPLETELY REMOVED THE SHEATH AND THE SCREW A SECOND TIME. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER TYPE OF FIXATION WITH NO PATIENT CONSEQUENCES BUT WITH A 15 MINUTE DELAY. THE CUSTOMER DISCARDED ALL OF THE COMPLAINT DEVICES.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7711315 ↗
• MalfunctionJul 17, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT THE SURGEON WENT TO USE AN INTRAFIX TIBIAL SHEATH AND IT HAS TWISTED AND BROKE WHILE HE WAS USING IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7696129 ↗
• MalfunctionJul 16, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL PROCEDURE THAT THE CUSTOMER'S INTRAFIX PEEK TAPERED SCREW WOULD NOT ADVANCE AFTER ABOUT HALF WAY OF BEING INSERTED. THE SCREW STARTED SPINNING, SO THE SURGEON BACKED OUT BOTH THE SHEATH AND SCREW AND USED ANOTHER SHEATH AND SMALLER SCREW TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7689937 ↗
• 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 OCLOCK POSITION. IT WAS A (B)(6) MALE PATIENT WITH HARD BONE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-51184.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7686449 ↗
• MalfunctionJul 9, 2018Break; Break

  IT WAS REPORTED THAT THE DEVICE HAS BEEN BROKEN DURING SCREWING SCREW INTO IT. TO COMPLETE THE PROCEDURE CUSTOMER USED ANOTHER ONE DEVICE THE SAME TYPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669148 ↗
• MalfunctionJul 9, 2018Break; Break

  IT WAS REPORTED THAT THE DEVICE HAS BEEN BROKEN DURING SCREWING SCREW INTO IT. TO COMPLETE THE PROCEDURE CUSTOMER USED ANOTHER ONE DEVICE THE SAME TYPE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7669131 ↗
• MalfunctionJul 3, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL PROCEDURE, HER INTRAFIX TIBIAL SHEATH BROKE WHEN THE SURGEON REMOVED THE DRIVER. THE SURGEON INSERTED THE SHEATH AND SCREW INTO THE BONE HOLE AND UPON REMOVAL OF THE DRIVER BROKE BOTH THE SHEATH AND SCREW. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE 1ST SET OF SHEATH AND SCREW WERE DISCARDED. THE SALES REP WAS NOT PRESENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7659011 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POSTOPERATIVE PAIN. THIS IS A LEGAL CASE. THE PATIENT ACCEPTED UNKNOWN PROCEDURE IN 2007. NO ANOMALIES WERE OBSERVED DURING AT THAT TIME. AFTER SEVERAL YEARS PATIENT FELT PAIN AND DOUBTED QUALITY OF IMPLANT. THEN PATIENT SUED HOSPITAL AND REQUESTED QUALITY CERTIFICATION OF DEVICE. FURTHER INFORMATION WILL BE UPDATED IF AVAILABLE.

  Patient problems: Pain

  MAUDE report 7562211 ↗
• MalfunctionMay 21, 2018Break; Break

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT DURING AN ACL PROCEDURE, THE DOCTOR INSERTED THE INTRAFIX TIBIAL SHEATH FINE, BUT WHEN HE WAS TRYING TO INSERT THE INTRAFIX PEEK SCREW, IT WOULD NOT SCREW IN THE BONE. THE DOCTOR STATED THE SHEATH WAS GETTING DAMAGED DUE TO THE PATIENT'S HARD BONE, AND REMOVED THE SHEATH. THE DOCTOR ATTEMPTED TO INSERT ANOTHER SHEATH AND SCREW, BUT THE SAME THING HAPPENED. THE DOCTOR THEN RE-DILATED THE HOLE AND USING THE SAME SIZE SHEATH AND SCREW SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. NO REPLACEMENT DEVICES WERE SENT OUT, JUST A TRUNK ADJUSTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7530151 ↗
• MalfunctionMay 21, 2018Break; Break

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT DURING AN ACL PROCEDURE, THE DOCTOR INSERTED THE INTRAFIX TIBIAL SHEATH FINE, BUT WHEN HE WAS TRYING TO INSERT THE INTRAFIX PEEK SCREW, IT WOULD NOT SCREW IN THE BONE. THE DOCTOR STATED THE SHEATH WAS GETTING DAMAGED DUE TO THE PATIENT'S HARD BONE, AND REMOVED THE SHEATH. THE DOCTOR ATTEMPTED TO INSERT ANOTHER SHEATH AND SCREW, BUT THE SAME THING HAPPENED. THE DOCTOR THEN RE-DILATED THE HOLE AND USING THE SAME SIZE SHEATH AND SCREW SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. NO REPLACEMENT DEVICES WERE SENT OUT, JUST A TRUNK ADJUSTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7529934 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150209, K983560. 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-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
• 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