NA 03.043.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982297198), received between Jan 3, 2023 and Jul 25, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CUSTOMER IN STERILE PROCESSING NOTIFIED THE REPRESENTATIVE THAT THEY WERE UNABLE TO DECOUPLE TWO ITEMS FROM TIBIAL NAIL ADVANCED SET POST-SURGERY: CONNECTING SCREW, CANNULATED, SHORT AND THE COMPRESSION SCREW, SHORT. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES. THIS REPORT INVOLVES ONE (1) COMPRESSION SCREW/ SHORT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827291 ↗
• MalfunctionFeb 28, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRODUCTS IN QUESTION WERE UNABLE TO BE STERILIZED AND ASSEMBLED. THERE WAS ALSO CHIPPING AND CRACKING, THEY WERE UNABLE TO BE USED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A COMPRESSION SCREW/ SHORT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18798395 ↗
• MalfunctionDec 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS COLD-WELDED TO THE CONNECTING SCREW. THERE WERE NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) COMPRESSION SCREW/ SHORT THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320083 ↗
• MalfunctionMay 22, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TNA INFRA APPROACH WAS DONE. NAIL WAS MALLETED IN, AIMING ARM CRACKED. AFTER COMPRESSING WITH COMPRESSION SCREW AND CONNECTING SCREW THE DRILL BIT HIT S1. SURGEON RE REAMED PROXIMALLY AND REAMER GOT SNAGGED PROXIMALLY. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) COMPRESSION SCREW/ SHORT THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16976616 ↗
• MalfunctionJan 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  THE EVENT WAS DISCOVERED DURING SURGERY ON (B)(6) 2022, BUT THE CONNECTING SCREW/COMPRESSION DEVICES WERE NOT BEING USED IN THE PROCEDURE. THE PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087022 ↗