INTRAFIX 254683Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705013647), received between Jun 30, 2018 and Jan 30, 2019 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED DURING ANTERIOR CRUCIATE LIGAMENT THE BIOINTRAFIX TIBIAL 30 MM AND FEMORAL INTRAFIX SHEATH 8.5 MM BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED USING A LIKE DEVICE IN THE SAME BONE HOLE. THE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8290607 ↗
• MalfunctionSep 10, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL REPAIR THAT THE TWO OF THE CUSTOMER'S INTRAFIX FEMORAL SHEATH AND SCREW SYSTEMS, 8MM, BROKE WHEN BEING INSERTED. THE SALES REP REPORTED THAT THE FIRST SHEATH, UNDER THE SCOPE, COULD BE SEEN TO BE BENDING AND TURNING A WHITE COLOR JUST BEFORE IT BROKE. THE SURGEON COMPLETELY REMOVED THIS SHEATH AND INSERTED A SECOND SHEATH, DIFFERENT LOT, IN THE SAME BONEHOLE WHEN UNDER THE SCOPE THEY COULD SEE IT BENDING AND TURNING WHITE AGAIN. THE SURGEON STOPPED INSERTING THE SHEATH AND ATTEMPTED TO REMOVE IT BEFORE IT BROKE BUT WAS UNABLE TO DO SO. THE SURGEON COMPLETELY REMOVED THIS SHEATH AND INSERTED A THIRD, DIFFERENT LOT NUMBER, SAME TYPE OF SHEATH IN THE SAME BONEHOLE AND COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP REPORTED THAT THE SURGEON DILATED THE TUNNEL ACCORDING TO OUR PROCEDURE AND THAT HIS ANGLE OF INSERTION WAS PERFECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7859112 ↗
• MalfunctionSep 10, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL REPAIR THAT THE TWO OF THE CUSTOMER'S INTRAFIX FEMORAL SHEATH AND SCREW SYSTEMS, 8MM, BROKE WHEN BEING INSERTED. THE SALES REP REPORTED THAT THE FIRST SHEATH, UNDER THE SCOPE, COULD BE SEEN TO BE BENDING AND TURNING A WHITE COLOR JUST BEFORE IT BROKE. THE SURGEON COMPLETELY REMOVED THIS SHEATH AND INSERTED A SECOND SHEATH, DIFFERENT LOT, IN THE SAME BONEHOLE WHEN UNDER THE SCOPE THEY COULD SEE IT BENDING AND TURNING WHITE AGAIN. THE SURGEON STOPPED INSERTING THE SHEATH AND ATTEMPTED TO REMOVE IT BEFORE IT BROKE BUT WAS UNABLE TO DO SO. THE SURGEON COMPLETELY REMOVED THIS SHEATH AND INSERTED A THIRD, DIFFERENT LOT NUMBER, SAME TYPE OF SHEATH IN THE SAME BONEHOLE AND COMPLETED THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP REPORTED THAT THE SURGEON DILATED THE TUNNEL ACCORDING TO OUR PROCEDURE AND THAT HIS ANGLE OF INSERTION WAS PERFECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7859110 ↗
• MalfunctionAug 5, 2018Break; Break

  THE SALES REP REPORTED THAT THE CUSTOMERS INTRAFIX FEMORAL SHEATH & SCREW SYSTEM 8.5MM ST, ONE OF THE ARMS WAS ATTACHED AND BROKE OFF; THE PATIENT HAD HARD BONE MATTER. THE SURGEON COMPLETES THE PROCEDURE USING ANOTHER LIKE DEVICE, WITH NO DELAY AND NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7749898 ↗
• MalfunctionJul 30, 2018Crack; Crack

  IT WAS REPORTED THAT WHEN THE DOCTOR INSERTED THE FEMORIAL INTRAFIX, THE SHEATH IS RUPTURED SO THE DOCTOR MUST REPLACE BY SIMILIAR PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7733935 ↗
• MalfunctionJul 30, 2018Crack; Crack

  IT WAS REPORTED THAT WHEN THE DOCTOR INSERTED THE FEMORAL INTRAFIX, THE SHEATH IS RUPTURED SO THE DOCTOR MUST REPLACE BY SIMILAR PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7733904 ↗
• MalfunctionJul 18, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THE CUSTOMER'S INTRAFIX 8.5 MM SCREW BROKE WHILE INSERTING INTO THE SHEATH DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE. HE STATED AS THE SURGEON WAS INSERTING THE SCREW, PART OF THE SHEATH FOLDED BACK AND THE SCREW CRACKED AND THEN BROKE INTO PIECES. THE SURGEON REMOVED ALL BROKEN FRAGMENTS OF THE SCREW AND INSERTED A NEW SCREW INTO THE SAME SHEATH TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. ALL BROKEN FRAGMENTS WERE DISCARDED ALREADY BY THE CUSTOMER. THE SALES REPRESENTATIVE STATED IT WAS STANDARD BONE QUALITY ON AN (B)(6) MALE. THIS WAS NO A REVISION SURGERY. NO FURTHER DETAILS COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699645 ↗
• MalfunctionJul 18, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE WHEN IMPLANTING THE SHEATH AND SCREW FROM THEIR FEMORAL INTRAFIX SYSTEM 8MM-8.5MMX23MM, THE SHEATH BACKED OUT OF THE TUNNEL. THE PROCEDURE WAS COMPLETED BY UPPING IN SIZE TO A BIGGER INTERFERENCE SCREW USING THE SAME BONE TUNNEL WITH NO HARM TO THE PATIENT BUT THERE WAS A FIVE MINUTE DELAY TO REMOVE THE SHEATH & SCREW AND TO FIGURE OUT THE NEXT BEST STEP. THE SALES REP STATED THAT THERE WAS NO EXCESSIVE FORCE AND THAT THE BONE QUALITY OF THE PATIENT WAS AVERAGE. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7698591 ↗
• MalfunctionJul 17, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S INFRAFIX FEMORAL SHEATH AND SCREW 8.5MM SYSTEM BROKE DURING AN ACL PROCEDURE. HE STATED THE SCREW BROKE IN HALF, NOT THE SHEATH. THE SURGEON REMOVED THE BROKEN ANCHOR AND ALL BROKEN PIECES AND INSERTED ANOTHER SCREW TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SCREW WAS DISCARDED BY THE CUSTOMER ALREADY. THE PATIENT WAS A (B)(6) FEMALE WITH AVERAGE BONE QUALITY. NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7695968 ↗
• MalfunctionJun 30, 2018Failure to Advance; Failure to Advance

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE AFTER THE SURGEON HAD DILATED THE SCREW FROM THE CUSTOMER'S FEMORAL INTRAFIX SYSTEM SHEATH & SCREW 8-8.5MMX23MM WAS TOO TIGHT IN THE FIXATION. THE SCREW WAS REMOVED WITH NO ISSUES AND WENT DOWN ONE SIZE TO COMPLETE THE FIXATION USING THE SAME BONE HOLE. DURING THE SAME CASE THE SURGEON HAD MADE THE GRAFT THICKER THAN USUAL AND DRILLED A 9 TUNNEL WHERE THE CUSTOMER'S BIOINTRAFIX TIBIAL SHEATH SMALL 30MM WAS TOO LOOSE IN THE FIXATION. THE SURGEON HAD TO GO TO A LARGE TIBIAL SHEATH TO COMPLETE THE FIXATION USING THE SAME BONE HOLE. THERE WAS NO PATIENT HARM OR DELAYS TO THE CASE. THE SALES REP STATED THAT THE PATIENT IS YOUNG WITH HARD BONE. THE SALES REP STATED THAT THE DEVICES WERE DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7653890 ↗

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-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-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