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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE ARTHRODESIS NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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STRYKER TRAUMA KIEL UNKNOWN T2 ANKLE ARTHRODESIS NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number UNK_KIE
Device Problem Migration (4003)
Patient Problem Insufficient Information (4580)
Event Date 06/26/2021
Event Type  Injury  
Manufacturer Narrative
This complaint has been generated based on findings discovered during post market surveillance literature review. The alleged cut out of the medial cortex of the calcaneum, requiring revision, could not be confirmed, since the device was not returned for evaluation and no other additional information was received from the author. More detailed information about the patient medical history, the event circumstances, radiographs and the involved device(s) must be available in order to determine the root cause. If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly. Device not available.
 
Event Description
The manufacturer became aware of a literature published by (b)(6) hospital, (b)(6). The title of this report is ¿¿a comparison of fibula pro-tibia fixation versus hindfoot nailing for unstable fractures of the ankle in those older than 60 years,¿ published on (b)(6) 2021, which is associated with the stryker ¿t2 ankle arthrodesis nail. ¿ the article can be found at doi: https://doi. Org/10. 1177/19386400211017373. This report includes analysis of the clinical data that was collected on 68 patients, and the cases in this study range from (b)(6) 2012 to (b)(6) 2018. During the review of the literature, it was not possible to establish a specific device detail, patient information, and at this time no additional device information is available. It was reported that 1 patient experienced early cut out of the medial cortex of the calcaneum, requiring revision. The report states, ¿in the case of surgical placement error, the calcaneal entry point was placed too medially resulting in early cut out of the medial cortex of the calcaneum on the postoperative radiographs. ¿.
 
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Brand NameUNKNOWN T2 ANKLE ARTHRODESIS NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer (Section G)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
GM D-24232
Manufacturer Contact
anna jusinski
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key14249934
MDR Text Key290377754
Report Number0009610622-2022-00159
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Literature
Reporter Occupation
Type of Report Initial
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
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
Date Manufacturer Received04/06/2022
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: 04/29/2022 Patient Sequence Number: 1
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