MAUDE Adverse Event Report: ZIMMER BIOMET, INC. AFFIXUS HFN A/R SCREW 85MM; ROD, FIXATION, INTRAMEDULLARY, AND ACCESSORIES/TRAUMA

Catalog Number	814501085
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369); Swelling/ Edema (4577)
Date of Event	05/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial orif with cephalomedullary nail left subtrochanteric hip fracture approximately ten (10) and a half months ago due.Subsequently, the patient underwent a revision surgery three (3) months later due to nonunion and a fractured implant that cause pain and swelling.
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: 814611400, hfn lh 130 deg 11mm x 400mm; lot#: 926300; item#: 814550042, cortical bone scr 5.0mm x 42mm; lot#: m36773c; item#: 814550042, cortical bone scr 5.0mm x 42mm; lot#: m35214twa.H3: customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4; b5; d2; g2; g3; g6; h1; h2.Upon receiving additional information, it was determined that this product did not cause the event.The initial report should be voided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: AFFIXUS HFN A/R SCREW 85MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY, AND ACCESSORIES/TRAUMA
• 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: 21150399
• Report Number: 0001825034-2025-00144
• Device Sequence Number: 9135067
• Product Code: HSB
• UDI-Device Identifier: 00887868566745
• UDI-Public: (01)00887868566745(17)330706(10)ZN1121285G
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: Health Professional
• Device Catalogue Number: 814501085
• Device Lot Number: ZN1121285G
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• 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 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male