NA 04.003.029SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982081629), received between Aug 13, 2021 and Sep 16, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS A CONCERN OVER THE STABILITY OF FX: REMOVAL OF NAIL AND SCREWS. AN IM REAMING OF FEMORAL CANAL WAS COMPLETED. THE SURGEON PUT IN LARGER NAIL / SUPPLEMENT WITH A PROXIMAL FEMUR HOOK PLATE. THIS REPORT IS FOR ONE (1) 6.5 TI RECON SCREW T25 SD 95-STERILE. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity

  MAUDE report 15438050 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS A CONCERN OVER THE STABILITY OF FX: REMOVAL OF NAIL AND SCREWS. AN IM REAMING OF FEMORAL CANAL WAS COMPLETED. THE SURGEON PUT IN LARGER NAIL / SUPPLEMENT WITH A PROXIMAL FEMUR HOOK PLATE. THIS REPORT IS FOR ONE (1) 6.5 TI RECON SCREW T25 SD 95-STERILE. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Laxity

  MAUDE report 15437826 ↗
• InjuryJul 8, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE REMOVAL OF BROKEN NAIL DUE TO NONUNION. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY. NO FRAGMENTS WERE GENERATED. THERE IS NO FURTHER INFORMATION. THIS REPORT IS FOR (1) 6.5 TI RECON SCREW T25 SD 95-STERILE. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14955098 ↗
• MalfunctionAug 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A SURGICAL PROCEDURE DUE TO A GUNSHOT WOUND WITH A NON DISPLACED BASALAR NECK FRACTURE. THE PATIENT HAD SUFFERED A GUNSHOT WOUND TO THE HIP WITH A NON DISPLACED BASALAR NECK FRACTURE THAT EXTENDED INTO THE TROCHANTERIC AREA. THE SURGEON HAD ORIGINALLY PLANNED TO GO WITH A TFNA, AND ELECTED TO GO WITH A FEMORAL RECON NAIL BECAUSE OF THE PATIENTS' SMALLER STATURE AND AGE. I ADVISED THAT THE FRN WAS NOT INDICATED FOR TROCHANTERIC TYPE FRACTURES, BUT ULTIMATELY THE SURGEON ELECTED TO USE THE NAIL. DURING THE CASE, THE 3.2 GUIDE PIN FOR THE RECON SCREW MISSED THE NAIL ON INITIAL ENTRY; HOWEVER IT WAS DETERMINED THAT SOFT TISSUE WAS BINDING ON THE SLEEVE. THE SLEEVES WERE READJUSTED, THE GUIDE PINS AND SCREWS WERE INSERTED PROPERLY. ULTIMATELY THERE WERE NO ALLEGATIONS AGAINST THE DEVICES OR ADVERSE EVENTS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCE. CONCOMITANT DEVCIE REPORTED: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1. THIS REPORT IS FOR ONE (1) 6.5MM TI RECON SCREW WITH T25 STARDRIVE 95MM-STERILE. THIS IS REPORT 2 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318344 ↗

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.