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U.S. Department of Health and Human Services

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

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ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 10MMX17.5CM 125R TRAUMA PROSTHESIS Back to Search Results
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.
 
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Brand NameZ NAIL CMF 10MMX17.5CM 125R
Type of DeviceTRAUMA 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 Key12589518
MDR Text Key275145969
Report Number0009613350-2021-00512
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
N/A
Number of Events Reported1
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 Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2498-180-10
Device Lot Number3052799
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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