INTRAFIX 254618Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886705013166), received between May 4, 2018 and Feb 8, 2023 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (15 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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 8, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING PROCESSING, IT WAS OBSERVED THAT THE INTRAFIX FAMILY SHEATH INSERTER DEVICE HAD PHYSICAL DAMAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DISTAL END WAS DEFORMED ON THE DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326795 ↗
• MalfunctionJan 23, 2023Break; Break

  IT WAS REPORTED BY THE SALES REP IN ITALY THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE INTRAFIX FAMILY SHEATH INSERTER DEVICE RUPTURED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16228034 ↗
• MalfunctionJan 11, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE INTRAFIX FAMILY TIBIAL SHEATHINSERTER DEVICE BROKE. THE PIECES WERE RETRIEVED AND PROCEDURE WAS COMPLETED AS PLANNED. THE PROCEDURE WAS DELAYED ABOUT 5 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13225845 ↗
• MalfunctionJan 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE DISTAL TIP ON THE INTRAFIX FAMILY TIBIAL SHEATH INSERTER DEVICE WAS BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13206450 ↗
• MalfunctionDec 17, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIXFAMILY TIBIAL SHEATHINSERTER DEVICE WAS BENT AT THE DISTAL END. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025643 ↗
• MalfunctionNov 24, 2020Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2020, IT WAS OBSERVED THAT THE INTRAFIX FAMILY TIBIAL SHEATH INSERTER DEVICE WAS BROKEN. ALL BROKEN FRAGMENTS WERE RETRIEVED. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE. IT WAS NOT REPORTED IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10895572 ↗
• MalfunctionSep 18, 2020Break; Break

  IT WAS REPORTED VIA COMPLAINT SUBMISSION TOOL THAT NURSING STAFF, EMAILED SALES REP AFTER THE CASE, TO INFORM THAT DURING AN ACL RECONSTRUCTION PROCEDURE, AN INTRAFIX FAMILY SHEATH INSERTER BROKE DURING USE. A SIMILAR INSTRUMENT AVAILABLE ON THE SHELF WAS OPENED AND USED TO COMPLETE PROCEDURE WITH A SURGICAL DELAY OF 5 MINUTES. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: Not Applicable

  MAUDE report 10557546 ↗
• MalfunctionAug 7, 2020Component Missing; Component Missing

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) PROCEDURE, IT WAS OBSERVED THAT THE END OF THE SHEATH WAS ALWAYS STICKING TO THE INTRAFIX FAMILY SHEATH INSERTER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT ONLY THE INTRAFIX FAMILY SHEATH INSERTER WAS RECEIVED AND THE CAPS AND THE TUBE WERE MISSING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379075 ↗
• MalfunctionDec 2, 2019Failure to Advance; Failure to Advance

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING AN ACL RECONSTRUCTION INTRAFIX FAMILY TIBIAL SHEATH INSERTER IS USUALLY A STRAIGHT SHAFT, HOWEVER IT SEEMS TO HAVE A TWIST AROUND THE SHAFT. BECAUSE OF THIS THE INTRAFIX FAMILY TIBIAL SHEATH INSERTER CAN NOT BE COMPLETELY PLACED ON THE SHAFT MAKING THE INSERTION OF THE SHEATH A LITTLE MORE DIFFICULT. THE SURGEON KEPT TRYING UNTIL IT WAS SUCCESSFULLY INSERTED. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9398135 ↗
• MalfunctionSep 26, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE INTRAFIX FAMILY TIBIAL SHEATH INSERTER WAS BROKEN IN HALF. THE CASE WAS REPORTED BY THE LOAN KIT TECHNICIAN DURING THE LOAN KIT INSPECTION AND IT WAS FORWARDED TO DEPUY ENGINEERING. NO PATIENT CONSEQUENCE AND NOR SURGICAL DELAYED WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9126495 ↗
• MalfunctionAug 29, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE INTRAFIX FAMILY TIBIAL SHEATH INSERTER BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8945034 ↗
• MalfunctionApr 2, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA CST TOOL THAT DURING AN ACL RECONSTRUCTION THE INTRAFIX INSERTER FOR 30MM SHEATH BROKE. IT IS UNKNOWN IF THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. PATIENT STATUS IS UNKNOWN. IT IS UNKNOWN IF ANY MEDICAL INTERVENTION WAS REQUIRED OR WHETHER THE PATIENT WAS PART OF A CLINICAL STUDY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475734 ↗
• MalfunctionMar 18, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT THE SHEATH INSERTER BROKE. THE AFFILIATE REPORTED NO PATIENT HARM OR TIME DELAY TO THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430000 ↗
• MalfunctionMar 18, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA E-MAIL THAT THE 30MM SEAT INSERTER HAS BEEN BROKEN. THERE WAS NO DELAY OR PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8429977 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED AT THE COMPLETION OF AN ANTERIOR CRUCIATE LIGAMENT REPAIR THE INTRAFIX FAMILY SHEATH INSERTER BROKE. THE PROCEDURE WAS COMPLETED PRIOR TO THE DEVICE BREAKAGE. THERE WAS NO PATIENT CONSEQUENCE OR SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288811 ↗
• MalfunctionJan 28, 2019Fracture; Fracture

  THE SALES REP REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE THE PIECE OF METAL AT THE DISTAL END OF THEIR INTRAFIX FAMILY SHEATH INSERTER BROKE OFF AND ARE UNABLE TO USE THE DEVICE. THE SALES REP STATED THAT THE DEVICE DID NOT BREAK IN THE PATIENT AND THAT THE DEVICE BROKE BEFORE BEING USED ON THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS OVER A YEAR OLD AND HAS SEEN HEAVY USE IN THE FIELD. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8281269 ↗
• MalfunctionJan 11, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONTRUCTION SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE INTRAFIX SHEATH INSERTER BROKE WHEN PLACED ON THE TRAY AFTER BEING REMOVED FROM THE PATIENT. THE SALES REP REPORTED THAT THE SHEATH CAME OUT WITH THE INSERTER AND THE SURGEON COMPLETED THE PROCEDURE USING JUST THE INTRAFIX SCREW. THE SALES REP REPORTED THAT THE SURGEON WAS SATISFIED WITH THE FIXATION. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS REPORTED. 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 8241649 ↗
• MalfunctionAug 21, 2018Break; Break

  IT WAS REPORTED THAT THE HEAD OF SHEATH INSERTER BROKE OFF FROM THE SHAFT OF THE INSERTER WHILE INSERTING THE TIBIAL SHEATH IMPLANT INTO THE TIBIAL TUNNEL. THE FRAGMENT REMAINED IN THE TUNNEL, AND HAD TO BE REMOVED BY THE SURGEON BEFORE THE SCREW COULD BE INSERTER. ACTION WERE TAKEN TO MANAGE THE PROBLEM DURING THE PROCEDURE. THE INSTRUMENT INSERTED THE SHEATH, SO ONCE THE BROKEN FRAGMENT WAS RETRIEVED, THE CASE WAS NORMAL: THERE WAS A 5 MINUTE DELAY TO PROCEDURE. THERE WERE NO ADVERSE EVENTS TO THE PATIENT. THE PATIENT OUTCOME POST SURGERY WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7803264 ↗
• MalfunctionAug 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL PROCEDURE BOTH THE CUSTOMER'S INTRAFIX SHEATH INSERTER AND FEMORAL SHEATH INSERTER BROKE AT THE HANDLE IN THIS CASE WHILE BEING MALLETED. THE SALES REP WAS NOT PRESENT AT THE CASE, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES. THEY SWAPPED THE DEVICES WITH OTHER LIKE DEVICES TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7775615 ↗
• MalfunctionJul 22, 2018Break; Break

  IT WAS REPORTED THAT WHILE USING THE SHEATH INSERTER ON A SAW BONES AND WHEN WE TOOK IT OUT OF THE SET THE TIP WAS BROKEN OFF. CANCELLED THE SAW BONES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7709550 ↗
• MalfunctionMay 4, 2018Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHILST PUTTING IN THE TIBIAL FIXATION DURING AN ACL THE END OF THE INVERTER SNAPPED OFF AND WAS RETAINED IN THE PATIENT. TO REMOVE THAT, THEY HAD TO DECONSTRUCT THE WHOLE STRUCTURE, AND EFFECTIVELY START AGAIN. THEY HAD A SECOND HANDLE TO IMPACT THE TIBIA, BUT NEEDED TO TAKE BOTH FEMORAL AND TIBIAL INTRAFIX IMPLANTS OUT AND REPLACE WITH NEW IMPLANTS. THERE WAS A 45 MINUTE DELAY TO PROCEDURE. NO AE TO PATIENT. ACCORDING TO THE HOSPITAL, THE PATIENT OUTCOME POST SURGERY WAS FINE.

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

  MAUDE report 7486300 ↗