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 Problems Non-union Bone Fracture (2369); Implant Pain (4561)

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 nonunion, 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, and patient information, and at this time no additional device information is available.It was reported that 7 patients experienced nonunion: it was reported that 5 patients experienced painful nonunion, requiring revision.It was reported that 2 patients experienced nonunion.

• 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: 14249867
• MDR Text Key: 290372258
• Report Number: 0009610622-2022-00156
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 5
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• 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 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: 04/06/2022
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention