INTRAFIX 254806Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10886705026722), received between Sep 11, 2020 and Sep 9, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  It was reported that during the surgery, when insert the INTRAFIX screw device, the screw was broken, all the pieces were removed from the patient. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698181 ↗
• MalfunctionSep 9, 2026Break

  It was reported that during the surgery, when inserting the INTRAFIX screw, the screw was broken. All the pieces were removed from the patient. Another device was used to complete the surgery. There were no reports of surgical delay. There were no adverse consequences to the patient. No additional information could be provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693434 ↗
• MalfunctionAug 27, 2026Break

  It was reported that during an Arthroscopic Ligament Repair procedure, it was discovered that the INTRAFX ADVBR SCW9X23 W/LGSHTH device broke off during implantation. All the broken parts were removed from the patient. It was not reported if there were any delays to the surgical procedure. It was reported that a spare device was used to complete the surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50475245 ↗
• MalfunctionAug 26, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50455783 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT DURING A POSTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH MENISCAL TEAR SURGERY, THE INTRAFIX DEVICE SCREW BROKE OFF AND THE SUTURE WAS KNOTTED. WHEN INSERTING THE SCREW, THE SCREW BROKE. ALL THE PIECES WERE REMOVED FROM THE PATIENT. THE USER CHANGED TO ANOTHER DEVICE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337318 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT DURING CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, WHEN THE INTRAFX ADVBR SCW7X30W/SMSHTH SCREW WAS INSERTED, IT WAS BROKEN. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568353 ↗
• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE INTRAFX ADVBR SCW7X30W/SMSHTH SCREW WAS INSERTED, THE SCREW BROKE. IT WAS REPORTED THAT ALL BROKEN PIECES WERE REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24032135 ↗
• MalfunctionDec 19, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW7X30W/SMSHTH ANCHOR DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT THE SURGEON REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856237 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW7X30W/SMSHTH DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346849 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY, IT WAS OBSERVED THAT THE INTRAFX ADVBR SCW7X30W/SMSHTH DEVICE ANCHOR WAS BROKEN OFF. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A TEN MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336784 ↗
• MalfunctionOct 7, 2025Crack; Crack

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT) REPAIR (ACL) SURGICAL PROCEDURE IT WAS OBSERVED THAT THE INTRAFX ADVBR DEVICE WAS BROKEN, THE SHEATH WAS CRACKED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23236168 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE INTRAFX ADVBR SCW7X30W/SMSHTH DEVICE ANCHOR WAS BROKEN, REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898075 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR (ACL) SURGICAL PROCEDURE THE INTRAFX ADVBR DEVICE ANCHOR WAS BROKEN. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A FIVE-MINUTE DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944072 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE INTRAFX ADVBR SCW7X30W/SMSHTH DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103120 ↗
• MalfunctionAug 12, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE THE UNSPECIFIED SURGICAL PROCEDURE THE INTRAFX ADVBR (B)(6)/SMSHTH DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19959428 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED, BY THE SALES REP IN CHINA. THAT DURING, AN CRUCIATE LIGAMENT RECONSTRUCTION SURGICAL PROCEDURE ON (B)(6) 2024. THE INTRAFX ADVBR SCW7X30W/SMSHTH DEVICE SCREWS WERE BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19743573 ↗
• MalfunctionJul 12, 2024Break; Break

  IT WAS REPORTED, BY THE SALES REP IN (B)(6). THAT DURING, AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE ON (B)(6) 2024. THE INTRAFX ADVBR SCW7X30W/SMSHTH DEVICE ANCHOR WAS BROKEN. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19733943 ↗
• MalfunctionSep 11, 2020Break; Break

  IT WAS REPORTED BY AFFILIATE IN (B)(6) THAT DURING ACL (ANT. CRUCIATE LIGAMENT) REPAIR) SURGERY ON (B)(6) 2020, IT WAS OBSERVED THAT THE ANCHOR DEVICE BROKE UPON INSERTION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10521402 ↗