MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 38 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The present report is being submitted as a replacement of 0001822565-2021-00784 submitted by (b)(6) as the product design belongs to winterthur.Kindly void medwatch report 0001822565-2021-00784 and consider the present medwatch report 0009613350-2021-00228.Concomitant medical products: tear drop guide wire 3.0 mm diameter 100 cm length; catalog#: 47-2490-097-00; lot#: 64867311.Znn, cmn lag screw, 10.5 mm, 110 mm including set screw; catalog#: 47-2485-110-10; lot#: 2940288.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head catalog#: 47-2484-037-50; lot#: 64850529.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head; catalog#: 47-2484-035-50; lot#: 64689229.3.0 mm threaded pin 305 mm length; catalog#: 00-2490-012-30; lot#: unknown.Znn, cmn threaded pin, 3.2 mm; catalog#: 00-2490-450-32; lot#: unknown.Therapy date: (b)(6) 2021.The manufacturer received x-rays and other source documents for review.The manufacturer received 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.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient was implanted on the right side and underwent a revision surgery due to implant fracture.

• Brand Name: CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 38 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: 11854096
• Report Number: 0009613350-2021-00228
• Device Sequence Number: 19837807
• Product Code: HSB
• UDI-Device Identifier: 00889024299870
• UDI-Public: 00889024299870
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-382-13
• Device Lot Number: 2706630R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/20/2021
• 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