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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL ANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE Ø10X150MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL ANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE Ø10X150MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 18191015S
Device Problem Failure to Advance (2524)
Patient Problem No Information (3190)
Event Date 02/06/2019
Event Type  malfunction  
Manufacturer Narrative
Device will not be returned. If additional information becomes available it will be provided on a supplemental report. Device disposition is unknown.
 
Event Description
Customer reported that the compression screw would not advance through the nail.
 
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Brand NameANKLE ARTHRODESIS NAIL, RIGHT T2 ANKLE Ø10X150MM
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
Manufacturer Contact
kevin smith
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8401842
MDR Text Key139326778
Report Number0009610622-2019-00096
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K051590
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number18191015S
Device Lot NumberK02481B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/07/2019 Patient Sequence Number: 1
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