NA 04.003.027SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982081582), received between Jan 15, 2018 and Jul 7, 2022 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 7, 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 ONE (1)6.5 TI RECON SCREW T25 SD 85-STERILE. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14950276 ↗
• MalfunctionNov 16, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT 6.5 TI RECON SCREW T25 SD 85-STERILE WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) 6.5MM TI RECON SCREW WITH T25 STARDRIVE 85MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819552 ↗
• 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 DEVICE 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 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318343 ↗
• InjuryJan 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL WAS PERFORMED DUE TO ATROPHIC NON-UNION OF A RIGHT FEMUR ON (B)(6) 2017. THE ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE; IT IS BELIEVED TO BE ABOUT A YEAR AGO. REMOVED HARDWARE INCLUDED: ONE NAIL AND TWO RECON SCREWS -ALL INTACT. THE REMOVAL WAS COMPLETED WITHOUT INCIDENT. THE PATIENT WAS REVISED TO A LARGE FRAGMENT PLATE AND SCREWS. BONE ASPIRATE AUTOGRAFT WAS USED FOR THE NON-UNION. IT IS NOTED THAT THE PATIENT IS ON FOSAMAX. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 6.5MM RECON SCREW. (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7189202 ↗
• InjuryJan 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A HARDWARE REMOVAL WAS PERFORMED DUE TO ATROPHIC NON-UNION OF A RIGHT FEMUR ON (B)(6) 2017. THE ORIGINAL PROCEDURE WAS PERFORMED ON AN UNKNOWN DATE; IT IS BELIEVED TO BE ABOUT A YEAR AGO. REMOVED HARDWARE INCLUDED: ONE NAIL AND TWO RECON SCREWS -ALL INTACT. THE REMOVAL WAS COMPLETED WITHOUT INCIDENT. THE PATIENT WAS REVISED TO A LARGE FRAGMENT PLATE AND SCREWS. BONE ASPIRATE AUTOGRAFT WAS USED FOR THE NON-UNION. IT IS NOTED THAT THE PATIENT IS ON FOSAMAX. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 6.5MM RECON SCREW. (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7189193 ↗

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.