ARCH, RETROGRADE TARGETING GUIDE 1281Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665017045), received between Mar 18, 2024 and May 16, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2024Break; Break

  ON 4/19/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A 1281-000 ARCH, RETROGRADE TARGETING GUIDE BROKE AT THE RETROGRADE FEMORAL NAIL JIG ARM PART DURING A CASE (PHOTO IS ATTACHED). THE CASE WAS COMPLETED SUCCESSFULLY USING A SYNTHES NAIL, WITH NO PIECES BREAKING INSIDE THE PATIENT OR DELAY IN THE CASE. THIS WAS DISCOVERED DURING A DISTAL FEMUR FRACTURE PROCEDURE ON (B)(4) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19330126 ↗
• MalfunctionMar 18, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06498818 THAT A 1280-000 TARGETING GUIDE AND A 1281-000 TARGETING GUIDE BROKE. DEBRIS WAS ABLE TO BE RECOVERED FROM THE PATIENT. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923757 ↗