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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH AFFIXUS NAIL TRAUMA IMPL

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ZIMMER SWITZERLAND MANUFACTURING GMBH AFFIXUS NAIL TRAUMA IMPL Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Material Integrity Problem (2978)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive x-rays for review. Other source documents were received and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. As no lot number was provided, the device history records could not be reviewed. 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 biomets reference number of this file is (b)(4).
 
Event Description
Patient was implanted on an unknown side and implant was fractured on (b)(6) 2021. Subsequently, underwent revision surgery.
 
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Brand NameAFFIXUS NAIL TRAUMA IMPL
Type of DeviceAFFIXUS NAIL TRAUMA IMPL
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 Key12040597
MDR Text Key257446363
Report Number0009613350-2021-00301
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 10/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/22/2021 Patient Sequence Number: 1
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