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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 9X160MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL

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ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, 9X160MM AFFIXUS(R) NATURAL NAIL(R) SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problems Mechanical Problem (1384); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problems Failure of Implant (1924); Insufficient Information (4580)
Event Date 08/27/2021
Event Type  malfunction  
Manufacturer Narrative
Medical products: blunt tip screw, 4x38mm; catalog#: 47-2486-038-40; lot#: 3024673; blunt tip screw, 4x40mm; catalog#: 47-2486-040-40; lot#: 3024681; blunt tip screw, 4x40mm; catalog#: 47-2486-040-40; lot#: 3024691; blunt tip screw, 4x56mm; catalog#: 47-2486-056-40; lot#: 3036148; cortical bone screw, 4x26mm; catalog#: 47-2486-126-40; lot#: 3039758; cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3054491; proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3054440. Therapy date: unknown. 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 implanted with ann nail on an unknown side. Three months from the initial surgery the surgeon found that the first proximal screw had backed out from its position. The surgeon is monitoring the patient and a revision surgery has not yet been planned.
 
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Brand NamePROXIMAL HUMERUS, RIGHT, 9X160MM
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 Key12539663
MDR Text Key274446339
Report Number0009613350-2021-00498
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
Report Date 11/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2496-160-09
Device Lot Number3049707
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2020
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: 09/28/2021 Patient Sequence Number: 1
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