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

Catalog Number UNK_KIE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged non-union 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.

Event Description

The manufacturer became aware of a literature published by diakonhjemmet hospital, oslo, norway.The title of this report is ¿retrograde nailing, trabecular metal implant and use of bone marrow aspirate concentrate after failed ankle joint replacement ¿, published on february 01, 2021, which is associated with the stryker ¿t2 ankle arthrodesis nail¿.The article can be found at https://doi.Org/10.1016/j.Fas.2020.03.003.This report includes analysis of the clinical data that was collected on 30 patients, and the cases in this study range from january 2016 to february 2019.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 2 patients experienced non-union.The report also states, ¿in two patients (6.5%) there were clear signs of non-union, one of them involving the subtalar joint and the other one both interphases of the tantalum cage (fig.2).To date, they have not been reoperated, despite a poor clinical outcome (patients are identified with yellow bars in fig.3).¿.

Event Description

The manufacturer became aware of a literature published by diakonhjemmet hospital, oslo, norway.The title of this report is ¿retrograde nailing, trabecular metal implant and use of bone marrow aspirate concentrate after failed ankle joint replacement ¿, published on february 01, 2021, which is associated with the stryker ¿t2 ankle arthrodesis nail¿.The article can be found at https://doi.Org/10.1016/j.Fas.2020.03.003.This report includes analysis of the clinical data that was collected on 30 patients, and the cases in this study range from january 2016 to february 2019.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 2 patients experienced non-union.The report also states, ¿in two patients (6.5%) there were clear signs of non-union, one of them involving the subtalar joint and the other one both interphases of the tantalum cage (fig.2).To date, they have not been reoperated, despite a poor clinical outcome (patients are identified with yellow bars in fig.3).¿.

Manufacturer Narrative

Correction: please refer to h1 summary report & h1 number of events summarized, h6 health impact code.Please note the h1 summary report tab and h1 number of events summarized tab were selected in error.This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of non-union could be confirmed, as a formal medical opinion was sorted out for the available data, although the x-ray is not giving reliable certainty a ct scan was performed which showed the non-union without a doubt, but no root cause can be derived from the provided x-ray.More detailed information about the patient medical history, the event circumstances, and medical reports must be available to determine the root cause.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

• Brand Name: UNKNOWN T2 ANKLE ARTHRODESIS NAIL
• Type of Device: ROD, 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 Key: 14251110
• MDR Text Key: 290389581
• Report Number: 0009610622-2022-00160
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Other