MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 10MMX17.5CM 125R TRAUMA PROSTHESIS

Model Number N/A

Device Problems Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/15/2021

Event Type  Injury  

Manufacturer Narrative

This product is manufactured by zimmer biomet winterthur and is not cleared or distributed in the u. S. However, this report is being submitted as zimmer biomet winterthur manufactures a similar device that is cleared or distributed in the united states. Medical product: z nail cmf 10. 5 x 90 lag scr; catalog# 47-2499-090-10; lot# 3054638; z nail cmf 5. 0x70 ant sup scr; catalog# 47-2501-070-50; lot# 3069176; z nail cmf nail cap 0mm; catalog# 47-2500-002-00 lot# 3056987; 5. 0 mm diameter cortical screw - red fixed angle 3. 5 mm hex head; catalog# 47-2484-025-50; lot# 64568583; 5. 0 mm diameter cortical screw - red fixed angle 3. 5 mm hex head; catalog# 47-2484-025-50; lot# 64930569; concomitant medical products: therapy date: (b)(6) 2021. The manufacturer did not receive x-rays, or other source documents 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. Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient was revised due to loosening and migration.

• Brand Name: Z NAIL CMF 10MMX17.5CM 125R
• Type of Device: TRAUMA PROSTHESIS
• 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: 12589518
• MDR Text Key: 275145969
• Report Number: 0009613350-2021-00512
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 47-2498-180-10
• Device Lot Number: 3052799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 10/07/2021 Patient Sequence Number: 1