MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 TIBIAL 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 11/27/2019

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged event of 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.

Event Description

The manufacturer became aware of a literature published by the ¿department of orthopaedics and trauma, the royal infirmary of edinburgh, uk¿.The title of this report is, ¿application of the radiographic union scale for tibial fractures (rust): assessment of healing rate and time of tibial fractures managed with intramedullary nailing¿, published on november 27, 2019, which is associated with the stryker ¿t2 tibia nailing system¿.The article can be found at https://doi.Org/10.1016/j.Otsr.2019.10.010.This report includes an analysis of the clinical data that was collected on 217 patients.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 16 patients experienced non-union, which required revisions: 11 patients underwent exchange intramedullary (im) nailing.4 patients had their im nails removed and an ilizarov frame applied.1 patient underwent a below-knee amputation.

Manufacturer Narrative

H1: this is not a summary report.The number of events summarized field is blank as this mdr submission pertains to one patient.Link to the published article: the article can be found at https://doi.Org/10.1016/j.Otsr.2019.10.010.

Event Description

The manufacturer became aware of a literature published by the ¿department of orthopaedics and trauma, the royal infirmary of edinburgh, uk¿.The title of this report is, ¿application of the radiographic union scale for tibial fractures (rust): assessment of healing rate and time of tibial fractures managed with intramedullary nailing¿, published on november 27, 2019, which is associated with the stryker ¿t2 tibia nailing system¿.This report includes an analysis of the clinical data that was collected on 217 patients.During the review of the literature, it was not possible to establish a specific device detail, patient information, and currently no additional device information is available.It was reported that 16 patients experienced non-union, which required revisions: 11 patients underwent exchange intramedullary (im) nailing.4 patients had their im nails removed and an ilizarov frame applied.1 patient underwent a below-knee amputation.The article can be found at https://doi.Org/10.1016/j.Otsr.2019.10.010.

• Brand Name: UNKNOWN T2 TIBIAL 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: 14457876
• MDR Text Key: 292183615
• Report Number: 0009610622-2022-00191
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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: 03/28/2024
• 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): Disability; Required Intervention