NA 03.010.480Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982068989), received between Feb 28, 2018 and Jun 17, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033618); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THE RADIOLUCENT AIMING ARM FOR ANTEGRADE STANDARD LOCKING AND LOCKING BOLT MEASURING DEVICE WERE BROKEN DURING A REVERSE LOGISTICS AUDIT OF RETURNED DEVICE AT MILLSTONE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) RADIOLUCENT AIMING ARM FOR ANTEGRADE STANDARD LOCKING. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10164287 ↗
• MalfunctionFeb 28, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PROCEDURE FOR FIXATION OF RETROGRADE/ANTEGRADE FEMORAL NAIL ON (B)(6) 2018, THE CANNULA SLEEVE IN A RADIOLUCENT AIMING ARM FOR ANTEGRADE STANDARD LOCKING WAS NOT GETTING LINED UP WITH THE NAIL. THE AIMING ARM WAS HITTING THE NAIL, INSTEAD OF GOING THROUGH THE LOCKING HOLE IN THE NAIL. A FREE HAND DRILL WAS USED IN PLACE OF RADIOLUCENT AIMING ARM FOR ANTEGRADE STANDARD LOCKING FOR COMPLETING THE SURGERY. THERE WAS A SURGICAL DELAY OF 25 MINUTES. THE SURGERY WAS COMPLETED WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: UNK - NAILS: RAFN (PART # UNKNOWN, LOT # UNKNOWN, QTY # UNKNOWN). (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7303985 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033618. One submission often covers many models, so check the product and lot details in each record.

• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.