NA 04.003.028SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982081605), received between Sep 28, 2020 and Sep 15, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K040336, K172157); 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.

• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 ALL IMPLANTS REMOVED WITHOUT INCIDENT. PATIENT WAS INFECTED. CLEAN OUT CANAL THROUGH REAMING AND IRRIGATION. IMPLANT OF AN ANTIBIOTIC COATED NAIL. NO IMPLANTS TO BE RETURNED. THIS REPORT IS FOR ONE (1) 6.5 TI RECON SCREW T25 SD 90-STERILE. THIS IS REPORT 3 OF 11 FOR COMPLAINT.

  Patient problems: Unspecified Infection

  MAUDE report 15429113 ↗
• MalfunctionSep 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  (B)(6) 2020: UPDATED EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A FEMORAL RECON NAIL PROCEDURE, THE UNKNOWN SCREWS AND THE UNKNOWN DRILL BIT HAVE MISSED THE UNKNOWN NAIL. THE CASE TURNED OUT FINE. IT WAS THE REPORTED THAT THE SUSPECTED DEVICES WERE THE RADIOLUCENT INSERTION HANDLE AND THE RADIOLUCENT AIMING ARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF FIVE (5) MINUTES. THERE WAS A MINOR SETBACK WITH THE UNKNOWN DRILL MISSING AS THE OUTCOME OF THE PROCEDURE. CONCOMITANT DEVICES REPORTED: PROTECTION SLEEVE(PART# 03.010.075, LOT# PE03465, QUANTITY: 1), PROTECTION SLEEVE(PART# 03.010.075, LOT# PE03466, QUANTITY: 1), DRILL SLEEVE (PART# 03.010.076, LOT#PE03467, QUANTITY: 2).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10595795 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040336, K172157. One submission often covers many models, so check the product and lot details in each record.

• Z-1915-2015 · May 27, 2015 · Terminated
  DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Sub
• Z-2058-2013 · Nov 2, 2012 · Terminated
  Synthes Trauma Nail System. The devices are indication for bone fixation.