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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: foreign- germany.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that patient underwent revision due to distal femur fixation plate fracture.The plate has fractured after osteosynthesis.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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 and/or corrected information.The following sections were updated: b4, b5, d1, d2, d4, d6, d9, g1, g3, g6, h1, h2, h3, h4, h6, h10.The plate was returned for investigation.The reported event can be confirmed as the plate presents a fracture through one of the hole that splits the plate in two pieces.Both surfaces of the plates show scratches and some polished areas.The fracture surfaces of the plate are irregular and show signs of material damage most likely due to relative contact of the two fracture pieces.A review of the device manufacturing records confirmed no abnormalities or deviations.Device is used for treatment.Medical records were not provided.With the available information, 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.On the fracture surfaces, beach lines are visible which point to a fatigue fracture.With the available information, 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d2, d9, g1, g3, g6, h1, h2, h3, h6, h10 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of manufacturing records cannot be performed without product identification.Device is used for treatment.Complaint history review cannot be performed without product identification.Medical records were not provided.With the available information, 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.H3 other text : product data not available.

• Brand Name: NCB®, FEMUR PLATE, RIGHT, 13 HOLES, 324 MM
• 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: 16643026
• Report Number: 0009613350-2023-00136
• Device Sequence Number: 12286453
• Product Code: HWC
• UDI-Device Identifier: 00889024297388
• UDI-Public: (01)00889024297388(11)170403(10)2903733
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: N/A
• 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,Followup
• Report Date (Section B): 07/06/2023

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 02.03260.013
• Device Lot Number: 2903733
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 04/19/2023; 06/07/2023; 06/27/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/04/2023; 06/22/2023; 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2017
• 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: Prefer Not To Disclose