MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN 125 DEG 9MM X 180MM; ROD, FIXATION

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Failure of Implant (1924)
Date of Event	08/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent a revision procedure due to nail fracture.The end broken nail could not be removed.It remains in patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Foreign source: france.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product remains implanted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D6: product was not explanted.Proposed code: mechanical (g04) - im nail.Supplier lot number 5982107 was provided.This was issued to zb lots 246460, 246440 and 030300.As such lot is unknown and all 3 lots will be investigated.Manufacture and expiration date for lots: m246460 05/06/2022-05/06/2032.M246440 05/22/2022-05/22/2032.M030300 04/20/2022-04/20/2032.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: HFN 125 DEG 9MM X 180MM
• 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: 15665731
• Report Number: 0001825034-2022-02410
• Device Sequence Number: 2748716
• Product Code: HSB
• UDI-Device Identifier: 00887868037962
• UDI-Public: (01)00887868037962(17)320420(10)030300
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100238
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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,Followup
• Report Date (Section B): 01/06/2023

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 Model Number: N/A
• Device Catalogue Number: 814309180
• Device Lot Number: 246460, 246440, 030300
• 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: 10/14/2022
• Supplement Date Received by Manufacturer: 11/04/2022; 12/14/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 12/01/2022; 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 60 KG