MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB®, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM; NCB PLATING SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
It was reported, that: there was a revision due to implant breakage.Patient outcome - revision due to implant fracture.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: a1, a3, b4, b5, g3, h1, h2, h6, h10 as no product nor photos of the product were returned, visual and dimensional evaluations could not be performed.Review of the device history records could not be performed due to missing lot number.The device is used for treatment.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: NCB®, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM
• Common Device Name: NCB PLATING SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14140001
• Report Number: 0009613350-2022-00242
• Device Sequence Number: 15030529
• Product Code: HRS
• UDI-Device Identifier: 00889024297388
• UDI-Public: 00889024297388
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042695
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.03260.013
• Device Lot Number: UNKNOWN
• 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: 03/22/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female