MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAIL; Rod, Fixation, Intramedullary And Accessories

Catalog Number	47249436011
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial implantation (orif) due to a femoral bone fracture after involvement in a motor vehicle accident as part of a clinical study.Subsequently, the patient underwent an explantation of the nails and screws approximately seven (7) months post-implantation due to discomfort in deep flexion and potential impingement of the distal locking screws.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# 47258407560; lot# d40460.Item# 47258405060; lot# j32679.Item# 47258403550; lot# f41483.Item# 47258403550; lot# f41443.Item# 47258700800; lot# l21537.G2: foreign - event occurred in the uk.H6: proposed component code - mechanical (g04) im nail.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAIL
• Common Device Name: Rod, Fixation, Intramedullary And Accessories
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 24745224
• Report Number: 0001822565-2026-01022
• Device Sequence Number: 21161907
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101622
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 47249436011
• Device Lot Number: 66486731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 09/30/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 21 YR
• Patient Sex: Male
• Patient Weight: 196 LB