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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X38MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL

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ZIMMER SWITZERLAND MANUFACTURING GMBH BLUNT TIP SCREW, 4X38MM AFFIXUS NATURAL NAIL SYSTEM HUMERAL NAIL Back to Search Results
Model Number N/A
Device Problem Patient Device Interaction Problem (4001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/24/2022
Event Type  malfunction  
Event Description
It was reported that a operation was performed with ann nail system. After 5 weeks from the initial, surgeon found one screw of the proximal screws was backed out from the proper position.
 
Manufacturer Narrative
Concomitant medical products: cortical bone screw, 4x28mm; catalog#: 47-2486-128-40; lot#: 3073722. Proximal humerus nail cap, 0mm; catalog#: 47-2488-010-00; lot#: 3076775. Blunt tip screw, 4x50mm; catalog#: 47-2486-050-40; lot#: 3024741. The manufacturer did not receive x-rays, or other source documents for review. The manufacturer did not receive the device for investigation. The lot number of the device was received. The device history records will be reviewed during investigation. 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). The following reports are associated with this event: 0009613350-2022-00172; 0009613350-2022-00173; 0009613350-2022-00175.
 
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Brand NameBLUNT TIP SCREW, 4X38MM
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 Key13868204
MDR Text Key288671885
Report Number0009613350-2022-00174
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 03/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2486-038-40
Device Lot Number3054317
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2020
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

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