EXPert Nail 04.013.360SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982087720), received between Oct 22, 2020 and Oct 22, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO NAIL BENT AND NON-UNION. THE PATIENT WAS INITIALLY IMPLANTED WITH ONE (1) TITANIUM RETRO/ANTEGRADE FEMORAL NAIL, AND FOUR (4) TITANIUM LOCKING SCREWS (SIZES 56MM/85MM/38MM/38MM) ON (B)(6) 2018. THE PATIENT WAS SUPPOSED TO HAVE A PLANNED SURGERY TO LENGTHEN THE IMPLANT OR ADD ANOTHER IMPLANT FOR LENGTHENING BUT THE PATIENT DID NOT SHOW UP DUE TO PERSONAL/FAMILY ISSUES SO THE PLANNED SURGERY DID NOT PUSH THROUGH THEN IT RESULTED FOR THE NAIL TO FATIGUE (FAIL) AND BENT. THE PATIENT WAS THEN RE-OPERATED AND NAIL EXCHANGE WAS DONE SUCCESSFULLY. THE PATIENT WAS STABLE AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: THE TITANIUM LOCKING SCREW WITH T25 STARDRIVE 56MM F/IM NAIL-STERILE (PART# 04.005.546S, LOT# H246755, QUANTITY 1). TITANIUM LOCKING SCREW WITH T25 STARDRIVE 85MM F/IM NAIL-STERILE(PART# 04.005.575S, LOT# H4982089, QUANTITY 1). TITANIUM LOCKING SCREW WITH T25 STARDRIVE 38MM F/IM NAIL-STERILE (PART# 04.005.528S, LOT# 714447, QUANTITY 1). TITANIUM LOCKING SCREW WITH T25 STARDRIVE 38MM F/IM NAIL-STERILE (PART# 04.005.528S, LOT# H729904, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT

  Patient problems: No Code Available

  MAUDE report 10722056 ↗

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.