MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB PP DIS FEM PLT L21H L393MM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient's condition was reported as having a broken ncb plate and a fracture in the same location as in the previous incident.Subsequently, a revision surgery was conducted.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).G2 - foreign: sweden.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h10.Visual examination of the returned product showed that the fractured ncb pp plate was returned for examination without any accessories such as screws and cerlage wires.The fracture of the plate is located through the center hole of a 3-hole pattern.On the fracture surfaces, beach lines are visible which point to a fatigue fracture.The fracture surfaces show also small polished areas and some scratches, most probably due to contact between the parts after the fracture.Several scratches/marks are visible on the surface on both sides of the plate.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint histories found no additional related complaints for this item and the reported part and lot combination.With the available information, a definitive root cause could not 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.

• Brand Name: NCB PP DIS FEM PLT L21H L393MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 17928662
• Report Number: 0009613350-2023-00577
• Device Sequence Number: 6472858
• Product Code: HRS
• UDI-Device Identifier: 00889024292925
• UDI-Public: (01)00889024292925(17)251031(10)2833056
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 03/20/2024

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: Lay User/Patient
• Device Expiration Date: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 0202264121
• Device Lot Number: 2833056
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 03/15/2024
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 01/16/2024; 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2015
• 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
• 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: Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female