MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN RH 130 DEG 9MM X 380MM; ROD, FIXATION

Model Number	8145-09-380
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had affixus nail implanted.Subsequently, revision procedure was performed to remove the fractured nail and external fixation was put in place.
Additional Manufacturer Narrative
This event was initially reported under mfr# : 0009613350 -2021 -00301.Event date: unknown day in (b)(6) 2021.Implant date: unknown day in (b)(6) 2020.Concomitant products: cat: 814510100 lot: wg1111300a hfn lag screw 10.5mm x 100mm.Cat: unknown screw lot: unknown.Cat: unknown screw lot: unknown.Report source: foreign- (b)(6).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00848, 0001825034 - 2022 - 00849, 0001825034 - 2022 - 00850.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, g3, g6, h1, h2, h3, h4, h6, h10 complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the nail is fractured.Fracture analysis was done on the nail and fatigue fractures were identified.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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 additional event information is available at the time of this report.

• Brand Name: HFN RH 130 DEG 9MM X 380MM
• Common Device Name: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 14052340
• Report Number: 0001825034-2022-00851
• Device Sequence Number: 14695944
• Product Code: HSB
• UDI-Device Identifier: 00887868038914
• UDI-Public: (01)00887868038914(17)250531(10)973540
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2022

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
• Device Expiration Date: 05/31/2025
• Device Model Number: 8145-09-380
• Device Catalogue Number: 814509380
• Device Lot Number: 973540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• 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: 03/11/2022
• Supplement Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2015
• 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: Female