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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL T2 ANKLE ARTHRODESIS NAIL IMPLANT

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STRYKER TRAUMA KIEL T2 ANKLE ARTHRODESIS NAIL IMPLANT Back to Search Results
Catalog Number UNK_KIE
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Bone Fracture(s) (1870)
Event Date 01/01/2005
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. Device evaluated by mfr: device disposition is unknown.
 
Event Description
The manufacturer became aware of a study from ¿university of (b)(6) school of medicine, (b)(6)¿ which was published in may 2015. The title of this study is ¿tibiotalocalcaneal arthrodesis using retrograde intramedullary nail fixation: comparison of patients with and without diabetes mellitus¿ and is associated with the stryker t2 ankle arthrodesis nail. Within that publication, post-operative complications/ adverse events were reported, which occurred between 1-jan-2005 until 30-jun-2013. It was not possible to ascertain specific device details from the report; a review of the complaint handling database, however, revealed that the event has not been reported by the hospital or by the author of the publication. Therefore, 68 complaint was initiated retrospectively for the different adverse event mentioned in the report. This product inquiry addresses tibia fracture at or above the proximal tip. 4 out of 4 cases. ¿four diabetic patients in our series (3. 4%) experienced a tibia fracture at or above the proximal tip of the nail (figs. 1 to 4). All of these fractures occurred in patients in whom we had used the shortest nail (150 mm), and all were successfully reconstructed by revising the 150-mm nail to the 300-mm nail. ¿.
 
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Brand NameT2 ANKLE ARTHRODESIS NAIL
Type of DeviceIMPLANT
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
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8642259
MDR Text Key146220133
Report Number0009610622-2019-00347
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_KIE
Device Lot NumberUNKNOWN
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 Received05/01/2019
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: 05/24/2019 Patient Sequence Number: 1
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