MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LH 130 DEG 11MM X 340MM; FEMUR INTRAMEDULLARY NAIL

Catalog Number	814611340
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial left femur fracture surgery.Subsequently, the patient was revised on approximately 1 month post-implantation due to the affixus nail breaking at the lag screw hole and required a conversion to arcos hemi.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
(b)(4).D10: hfn lag screw 10.5mm x 90mm; pn: 814510090; ln: xj1112290a.Cortical bone scr 5.0mm x 42mm; pn: 814550042; ln: m17986b.Cortical bone scr 5.0mm x 46mm; pn: 814550046; ln: m34441a.Hfn a/r screw 75mm; pn: 814501075; ln: zn1122275e.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h4; h6 h6: proposed annex g: mechanical (g04) - im nail the reported is confirmed through review of photographs and medical records.Visual examination of the provided photographs confirmed that the nail is fractured at the screw hole.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Radiographs were provided.Images were not submitted for further review as explant photos provide sufficient evidence for the investigation.A definitive root cause cannot be determined.If any further information is found 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: HFN LH 130 DEG 11MM X 340MM
• Common Device Name: FEMUR INTRAMEDULLARY NAIL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23422693
• Report Number: 0001825034-2025-03405
• Device Sequence Number: 20896426
• Product Code: HSB
• UDI-Device Identifier: 00887868039805
• UDI-Public: (01)00887868039805(17)290821(10)185170
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 814611340
• Device Lot Number: 185170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2019
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Unknown