MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did receive per for review.The manufacturer did not receive the device for investigation.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.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.(b)(4).
Event or Problem Description
Patient was implanted on the unknown side and underwent revision surgery due to implant fracture.
Additional Manufacturer Narrative
Event description: it was reported that the patient was implanted with a znn nail in the right femur on (b)(6) 2020.When the patient visited the hospital on (b)(6) 2020 it was noticed from the x-ray that the implant had fractured.Subsequently, the patient underwent revision surgery on (b)(6) 2020.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: an undated radiograph of the right hip and proximal thigh was presented.The radiograph was photographed from a computer screen and is of poor image quality due to light reflection.It can be seen that the axis of the proximal nail part (above the lag screw) is slightly out of line with the nail axis.Patient data: patient information was not provided due to patient privacy policy.Product evaluation: the product was not returned by the hospital; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is 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.Conclusion: it was reported that the patient was implanted with a znn nail in the right femur on (b)(6) 2020.When the patient visited the hospital on (b)(6) 2020 it was noticed from the x-ray that the implant had fractured.Subsequently, the patient underwent revision surgery on (b)(6) 2020.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the radiograph provided, the reported nail fracture can be confirmed.However, due to the unavailability of the reported device and the lack of medical data, the exact cause cannot be determined.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 21.5 CM
• Common Device Name: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11162728
• Report Number: 0009613350-2021-00010
• Device Sequence Number: 10914405
• Product Code: HSB
• UDI-Device Identifier: 00889024298934
• UDI-Public: 00889024298934
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-212-13
• Device Lot Number: 2869577
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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