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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X44MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

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ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X44MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problems Patient Device Interaction Problem (4001); Migration (4003)
Patient Problem Failure of Implant (1924)
Event Date 01/06/2022
Event Type  Injury  
Manufacturer Narrative
Medical product: ann ph nail rt 8. 5x260mm; catalog#: 47-2496-260-08; lot#: 3038171. Therapy date: (b)(6) 2022. The manufacturer received x-rays and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. Lot number were received for the device, 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 there was a revision surgery due to migration. Screw toggled out of the nail, even with the core lock that was locked during surgery.
 
Event Description
It was reported that there was a revision surgery due to migration. Screw toggled out of the nail, even with the core lock that was locked during surgery.
 
Manufacturer Narrative
Medical product: ann ph nail rt 8. 5x260mm; catalog#: 47-2496-260-08; lot#: 3038171. Therapy date: (b)(6) 2022. The manufacturer received x-rays and will be reviewed as part of ongoing investigation. The manufacturer did not receive the device for investigation. Lot number were received for the device, 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).
 
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Brand NameBLUNT TIP SCREW, 4X44MM
Type of DeviceAFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL
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 Key13583766
MDR Text Key285988398
Report Number0009613350-2022-00099
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K181827
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 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2486-044-40
Device Lot Number3024702
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/18/2020
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: 02/23/2022 Patient Sequence Number: 1
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