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U.S. Department of Health and Human Services

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

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ZIMMER SWITZERLAND MANUFACTURING GMBH PROXIMAL HUMERUS, RIGHT, Ã 11X160MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 02/09/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: therapy date: (b)(6) 2022. Cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3054458. Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3054381. Cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3064872. Blunt tip screw, 4x44mm; catalog#: 47-2486-044-40; lot#: 3039762. Proximal humerus, right, 11x160mm; catalog#: 47-2496-160-11; lot#: 3059662. Torque limiting handle; catalog#: 27923; lot#: unknown. Event description: operation was performed with ann nail on (b)(6) 2021. After 7 weeks from the initial, surgeon found the #3 proximal screw was backed out from the proper position. Therefore, revision surgery was conducted on feb 9, and only migrated screw was explanted. Review of received data: no medical records available. Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested. Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed. Review of product documentation: device purpose: all involved devices are intended for treatment. Product compatibility: the product combination was approved by zimmer biomet. Surgical technique: explains that the locking of the corelock is done using the corelock driver with torque limiting handle. Turn slowly clockwise to tighten and engage the corelock mechanism until a click is felt from the torque limiting handle. Dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found. A complaint history was run which identified additional complaints for the reported product and lot number. Conclusion: operation was performed with ann nail on (b)(6) 2021. After 7 weeks from the initial, surgeon found the #3 proximal screw was backed out from the proper position. Therefore, revision surgery was conducted on feb 9, and only migrated screw was explanted. The quality records show that all specified characteristics have met the specifications valid at the time of production. Based on the investigation it could be assumed that further possible contributing factors to the migration of the screw might be multifactorial related to either patient condition, behavior or implantation procedure. If and to what extent any of these aspects may have influenced the migration of the screw remains unknown. A deeper investigation was performed (refer to (b)(4)) which identified the design limitation of the corelock mechanism as a potential contributing factor as well. However, further biomechanical testing was carried out and as the product performance is in an acceptable range in comparison with legally marketed similar devices, no design changes were conducted. In conclusion, as the cause may be multifactorial an exact root cause could not be identified for the migration of the screw. The need for corrective measures is not indicated and zimmer (b)(4) manufacturing gmbh considers this case as closed. Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
It was reported that a operation was performed with ann nail system. After 7 weeks from the initial, surgeon found one of the proximal screw was backed out from the proper position. Therefore, revision surgery was conducted and only migrated screw was explanted.
 
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Brand NamePROXIMAL HUMERUS, RIGHT, Ã 11X160MM
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 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 Key14710760
MDR Text Key294663550
Report Number0009613350-2022-00344
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
Report Date 06/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2022
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 Number3059662
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/16/2022 Patient Sequence Number: 1
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