MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN RH 125 DEG 9MM X 340MM; ROD, FIXATION

Catalog Number	814309340
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: germany.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Upon receipt of additional information or completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that a patient underwent an initial hip fracture fixation procedure.Subsequently, three (3) months post-implantation, the patient presented with pain and mobility difficulties.Diagnostic images revealed a fracture of the implanted femoral fixation nail.The patient underwent revision surgery of the affected nail six (6) months post-implantation without reported complication.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code: mechanical (g04) - im nail.Visual examination of the returned product/provided pictures identified signs of use with scratches on the outside of the nail.The threads inside the nail are also damaged.The nail has fractured into 2 pieces near the top of the nail.There were also 2 unknown screws and a threaded cannulated device returned with the nail.Optical images of the device fracture surface show beach marks artifacts suggesting a fatigue mode of failure.Device history record was reviewed and no discrepancies related to the reported event were found.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right femoral intramedullary rod with eventual fracture at the level of the femoral neck screw.Comminuted fracture of the proximal right femur with involvement of the greater and lesser trochanter as well as the proximal humeral diaphysis which is still not yet healed at the time of hardware fracture.Root cause was unable to be determined.Reported event was confirmed by review of provided radiographs.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.
Event or Problem Description
No further event information at time of this report.

• Brand Name: HFN RH 125 DEG 9MM X 340MM
• Common Device Name: ROD, FIXATION
• 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: 18528354
• Report Number: 0001825034-2024-00119
• Device Sequence Number: 20436075
• Product Code: HSB
• UDI-Device Identifier: 00887868038013
• UDI-Public: (01)00887868038013(17)320515(10)246520
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: Health Professional
• Device Catalogue Number: 814309340
• Device Lot Number: 246520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Prefer Not To Disclose