INTRAFIX 254682Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705013630), received between Jul 13, 2018 and Nov 5, 2018 — 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.

• MalfunctionNov 5, 2018Crack; Crack

  THE SALES REPRESENTATIVE REPORTED ONE OF THE CUSTOMER'S INTRAFIX FEMORAL SHEATH AND SCREW SYSTEM CRACKED UPON INSERTION DURING AN ACL PROCEDURE. THE SURGEON DECIDED TO KEEP THE DEVICE IN THE PATIENT AND THAT HE HAD GOOD FIXATION. THERE WERE NO PATIENT CONSEQUENCE OR DELAYS. THE SALES REPRESENTATIVE WAS NOT PRESENT, NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038070 ↗
• MalfunctionJul 18, 2018Break; Break

  THE SALES REP REPORTED THAT DURING AN ACL REPAIR THAT HIS INTRAFIX FEMORAL SHEATH AND SCREW SYSTEM BROKE WHEN INSERTED INTO THE BONEHOLE. THE SURGEON COMPLETELY REMOVED THE SCREW AND SHEATH. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE DEVICE WAS ALREADY DISCARDED BY THE CUSTOMER. THE SALES REP WAS NOT PRESENT. NO FURTHER INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7701498 ↗
• MalfunctionJul 16, 2018Break; Break

  THE SALES REP REPORTED DURING AN ACL PROCEDURE, THE CUSTOMER'S INTRAFIX 8.0MM SCREW CRACKED ON THE LAST 2-3 TURNS. THE SALES REP STATED THE PATIENT HAD HARD BONE AND THE SURGEON FELT THE FIXATION WAS FINE, HE LEFT THE SCREW IN, BUT WAS DISAPPOINTED WITH THE PRODUCT. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7691083 ↗
• MalfunctionJul 13, 2018Break; Break

  THE SALES REP REPORTED THAT DURING AN ACL REPAIR THAT HIS INTRAFIX FEMORAL SCREW 8 MM BROKE WHEN IT WAS 3/4 OF THE WAY INSERTED. THE SALES REP REPORTED THE TUNNEL SIZE WAS 9 MM AND THE GRAFT WAS 8 MM 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 A (B)(6)YEAR OLD FEMALE WITH GOOD 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 7686254 ↗

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-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-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-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-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