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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 11X160MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

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ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 11X160MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)
Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/18/2021
Event Type  Injury  
Manufacturer Narrative
Medical product: blunt tip screw, 4x48mm; item# : 47248604840; lot# : 3024731. Blunt tip screw, 4x46mm; item# : 47248604640; lot# : 3039376. Blunt tip screw, 4x46mm; item# : 47248604640; lot# : 3062600. Cortical bone screw, 4x32mm; item# : 47248613240; lot# : 3010610. Proximal humerus nail cap, 10. 5x2. 5mm; item# : 47248801002; lot# : 3025182. Proximal humerus nail cap,11x2. 5mm; item# : 47248801102; lot# : 3038374. Therapy date: (b)(6) 2021. 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
Patient was implanted on an unknown side. 1 week post the surgery, it was noticed by the surgeon that the blunt screw gradually backed out from the proper position. A revision surgery was performed and during the revision only the blunt screw was explanted.
 
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Brand NamePROXIMAL HUMERUS, RIGHT, 11X160MM
Type of DeviceAFFIXUS(R) NATURAL NAIL(R) 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 Key12421520
MDR Text Key269786483
Report Number0009613350-2021-00446
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K200814
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 11/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2496-160-11
Device Lot Number3051302
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2020
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: 09/03/2021 Patient Sequence Number: 1
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