NA 2361-5045SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327381665), received between Oct 14, 2019 and Jun 20, 2023 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Break; Fracture; Mechanical Jam; Break; Fracture; Mechanical Jam

  IT WAS REPORTED: "THE SURGEON WAS DOING AN INTRAMEDULLARY NAILING ON THE LEFT. WHILE INSERTING THE DISTAL TIBIAL SCREW, IT GOT STUCK. WHILE TRYING TO REMOVE THE SCREW, ONLY PART OF THE PIECE CAME OUT. THE REMAINDER OF THE SCREW IS STILL IN THE PATIENT. THE SURGEON MADE THE DECISION TO LEAVE THE SCREW IN AS OPPOSED TO RISK CAUSING HARM TO THE PATIENT BY TRYING TO REMOVE IT".

  Patient problems: Foreign Body In Patient

  MAUDE report 17162712 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "ORIF FOR RIGHT TIBIA WAS PERFORMED. DURING SURGERY, LOCKING FAILURE OF THE ADVANCED LOCKING SCREW WAS HAPPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457203 ↗
• MalfunctionFeb 28, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "ORIF FOR RIGHT TIBIA WAS PERFORMED. DURING SURGERY, LOCKING FAILURE OF THE ADVANCED LOCKING SCREW WAS HAPPENED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455751 ↗
• MalfunctionJun 10, 2020Migration; Migration

  THE REPRESENTATIVE WAS PROVIDED A PICTURE OF AN X-RAY SHOWING A T2 ALPHA GREATER TROCH NAIL WITH THE DISTAL LOCKING SCREW BACKING OUT. SURGEON'S TEXT STATES: "WHY IS IT THAT THE LOCKING DISTAL SCREWS BACKED OUT BUT THE REGULAR SCREW DID NOT?" NO REVISION WAS REPORTED FOR THE PATIENT AT THIS TIME.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 10140780 ↗
• InjuryApr 8, 2020Migration; Migration

  THIS REPORT IS FOR THE FIRST SCREW BACK-OUT ("THE MOST DISTAL T2 ALPHA SCREW"). AS REPORTED: "THE MOST DISTAL T2 ALPHA SCREW IN THE TIBIA NAIL BACKED OUT AND HAD TO BE REMOVED. THE SCREW WAS AN ADVANCED LOCKING SCREW AND WAS REMOVED IN CLINIC. TWO DAYS LATER, THE OTHER 2 DISTAL SCREWS (ADVANCED LOCKING SCREWS) ALSO BACKED OUT. THIS EVENT HAPPENED 2 AND 2.5 WEEKS POST OP".

  Patient problems: Failure of Implant; Injury

  MAUDE report 9941552 ↗
• InjuryOct 15, 2019Failure to Advance; Migration; Migration

  PRODUCT MANAGER REPORTED THAT : " IN THE 3-MONTH RADIOGRAPHIC EXAMINATION AFTER SURGERY WITH T2 ALPHA TIBIA NAIL: THERE ARE TWO ADVANCED T2 ALPHA SCREWS THAT HAVE BEGUN TO MOVE." ADDITIONAL INFORMATION REPORTED: REMOVAL OF THE SCREW IS PLANNED SEPTIC PSEUDARTHROSIS OF THE TIBIA: SURGERY WITH EXTERNAL FIX AND THEN BY EVOLUTIVE NAIL SINCE 1Y. ALPHA NAIL IMPLANTED ON (B)(6) 2019. RETREAT OF THE 2 MEDIAL LATERAL DISTAL SCREWS AT 1 MONTH. STANDARD DISTAL ANTERIOR POSTERIOR DISTAL SCREW (NOT ADVANCED). EVENT IDENTIFIED POST-OPERATIVE. PATIENT INVOLVEMENT: YES; WALK WITHOUT SUPPORT PROMULGATED FOR AN ADDITIONAL 6 WEEKS.

  Patient problems: Ambulation or Postural Difficulties; Injury; No Patient Involvement

  MAUDE report 9194937 ↗
• InjuryOct 14, 2019Failure to Advance; Migration; Migration

  PRODUCT MANAGER REPORTED THAT : " IN THE 3-MONTH RADIOGRAPHIC EXAMINATION AFTER SURGERY WITH T2 ALPHA TIBIA NAIL: THERE ARE TWO ADVANCED T2 ALPHA SCREWS THAT HAVE BEGUN TO MOVE." ADDITIONAL INFORMATION REPORTED: REMOVAL OF THE SCREW IS PLANNED SEPTIC PSEUDARTHROSIS OF THE TIBIA : SURGERY WITH EXTERNAL FIX AND THEN BY EVOLUTIVE NAIL SINCE 1Y. ALPHA NAIL IMPLANTED ON (B)(6) 2019. RETREAT OF THE 2 MEDIAL LATERAL DISTAL SCREWS AT 1 MONTH. STANDARD DISTAL ANTERIOR POSTERIOR DISTAL SCREW (NOT ADVANCED). EVENT IDENTIFIED POST-OPERATIVE. PATIENT INVOLVEMENT: YES; WALK WITHOUT SUPPORT PROMULGATED FOR AN ADDITIONAL 6 WEEKS.

  Patient problems: Ambulation or Postural Difficulties; Injury; No Patient Involvement

  MAUDE report 9188432 ↗