MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 12 HOLES, 285 MM; NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/02/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: the patient underwent a trauma plate revision 2.5 months¿ post-implantation due osteosynthesis failure which led to implant fracture.
Additional Manufacturer Narrative
The investigation of the reported event currently is ongoing.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).
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Investigation and conclusion 1.Event description: it was reported that a plate was implanted on (b)(6) 2021.Readmission due to osteosynthesis failure - plate fracture on (b)(6) 2021.Re-osteosynthesis necessary.Incorrect loading on the part of the patient.Patient involved.No delay.Harm: s3 - instability, moderate hazardous situation: implant deteriorates, breaks or loses function postoperatively.2.Review of medical record and/or radiograph review: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: there are several x-rays available for investigation.The plate and sub components were implanted on (b)(6) 2021.The post operative pictures dated (b)(6) 2021 shows a good reduction of the fracture and a good plate osteosynthesis.There are no pictures available which shows the breakage of the plate.The plate was revised on (b)(6) 2021.Surgical report: surgical report, dated (b)(6) 2021: the surgical report of the revision was available.The report describes that the plate was broken at the same area where the initial bone fracture was located and that the post operative restrictions were not followed by the patient.It is also mentioned that a cerclage wire was implanted below the fracture of the plate.The broken plate was removed and replaced with a new plate with the same size.3.Product evaluation: visual examination: the broken ncb pp plate and screws were returned for investigation.The plate was broken into two fragments.The fracture of the plate is located through a screw hole.On the fracture surfaces, beach lines are visible which point to a fatigue fracture.The fracture origins are located at the beginning of the chamfer on the non-bone-facing side.On the fracture surfaces there are polished areas and some scratches, probably due to contact between the parts after the fracture.Additionally, next to the fracture, marks and polishing are visible which presumably could have derived from contact with the cerclage wires which was used for fracture fixation.4.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the product combination was approved by zimmer biomet dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Raw material certificate: the raw material certificate was reviewed with no anomalies noted.Surgical technique: in the surgical technique it is described that ncb bone spacers may also be used if the fracture has been reduced using a cable, to avoid contact between the plate and the cable wire.Insert the adequate bone spacers into ncb screw holes before plate insertion.Complaint history review: review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.5.Conclusion: it was reported that a plate was implanted on (b)(6) 2021.Readmission due to osteosynthesis failure - plate fracture on (b)(6) 2021.Re-osteosynthesis necessary.Incorrect loading on the part of the patient.Patient involved.No delay.The quality records show that all specified characteristics (material, dimensions, surface, etc.) for the ncb pp plate have met the specifications valid at the time of production.The raw material certificate of the plate was reviewed with no anomalies noted.The investigation did not identify a nonconformance or a complaint out of box (coob).The visual examination of the plate indicates a fatigue fracture.Macroscopically, no defects can be observed that could trigger or contribute to the fracture.Fatigue fractures can occur due to a cyclic overloading.Possible contributing factors to the overload could be a not properly healed bone fracture and / or not adherence to the postoperative protocol (patient behavior).On the backside of the plate there are polished areas and structured marks visible where the cerclage wires were placed.The surgical report and x-rays show that the plate was fixed with using cables.In the surgical technique it is described that ncb bone spacers may also be used if the fracture has been reduced using a cable, to avoid contact between the plate and the cable wire: insert the bone spacers into ncb screw holes before plate insertion.Not using spacers might have led to high bending stresses where the plate was in direct contact with the cerclage wire (lever arm situation).However, an exact root cause for the breakage of the ncb pp plate could not be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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
Investigation results are now available.

• Brand Name: NCB, PERIPROSTHETIC FEMUR PLATE, PROXIMAL, LEFT, 12 HOLES, 285 MM
• Common Device Name: NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE 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: 13266257
• Report Number: 0009613350-2022-00029
• Device Sequence Number: 1546464
• Product Code: HRS
• UDI-Device Identifier: 00889024292758
• UDI-Public: 00889024292758
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/11/2022

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 02.02263.112
• Device Lot Number: 3056942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 01/17/2022
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2020
• 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 Age: 67 YR
• Patient Sex: Female