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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 11.5MM X 32CM 125 L ZIMMER NATURAL NAIL SYSTEM FORTIS NAIL, LONG LEFT

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ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 11.5MM X 32CM 125 L ZIMMER NATURAL NAIL SYSTEM FORTIS NAIL, LONG LEFT Back to Search Results
Model Number N/A
Device Problems Patient Device Interaction Problem (4001); Migration (4003)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
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 105 lag scr; item#47249910510; lot#3065731; z nail cmf nail cap 0mm; item# : 47250000200; lot# : 3056988. 5. 0 mm diameter cortical screw - red fixed angle 3. 5 mm hex head; item# : 47248403550; lot# : 64923937. 5. 0 mm diameter cortical screw - red fixed angle 3. 5 mm hex head; item# : 47248404250; lot# : 64661205. Z nail cmf 5. 0x85 ant sup scr; item# : 47250108550; lot# : 3050807. Therapy date: unknown. The manufacturer received x-rays and other source documents for review. 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
The patient received an implant on left side and 4 weeks post the implantation surgery, radiological findings revealed that the lag screw migrated towards the outer side. The patient is being monitored and no revision has been planned so far.
 
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Brand NameZ NAIL CMF 11.5MM X 32CM 125 L
Type of DeviceZIMMER NATURAL NAIL SYSTEM FORTIS NAIL, LONG LEFT
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 Key12432729
MDR Text Key271647691
Report Number0009613350-2021-00471
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 11/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2498-321-11
Device Lot Number3052633
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/26/2020
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: 09/07/2021 Patient Sequence Number: 1
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