MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 SUPRACONDYLAR NAIL (SCN); ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/22/2017

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the department of orthopaedic surgery, toyota memorial hospital, japan.The title of this report is ¿clinical outcome of retrograde intramedullary nail and locking plate for distal femoral fracture ¿, published on december 22, 2017, which is associated with the stryker ¿t2 supracondylar nailing system¿.The article can be found at https://doi.Org/10.11359/chubu.2017.937.This report includes an analysis of the clinical data that was collected on 39 patients, and the cases in this study range from september 2005 to march 2016.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 1 patient experienced pseudarthrosis, which required revision surgery.The report states, ¿in the case that required revision surgery in the im group, an x-ray examination immediately after surgery showed anterior perforation at the proximal part of the intramedullary nail.Although the perforation was treated conservatively using external fixation and the patient¿s progress was monitored, the perforation progressed, so we replaced the intramedullary nail with a long nail and bone union was eventually achieved.¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged pseudarthrosis, which required revision surgery, 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.

Manufacturer Narrative

Correction: h1: this is not a summary report.The number of events summarized field is blank as this mdr submission pertains to one patient.H6: corrections in health impact codes.

Event Description

The manufacturer became aware of a literature published by the department of orthopaedic surgery, toyota memorial hospital, japan.The title of this report is ¿clinical outcome of retrograde intramedullary nail and locking plate for distal femoral fracture ¿, published on december 22, 2017, which is associated with the stryker ¿t2 supracondylar nailing system¿.The article can be found at https://doi.Org/10.11359/chubu.2017.937.This report includes an analysis of the clinical data that was collected on 39 patients, and the cases in this study range from september 2005 to march 2016.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 1 patient experienced pseudarthrosis, which required revision surgery.The report states, ¿in the case that required revision surgery in the im group, an x-ray examination immediately after surgery showed anterior perforation at the proximal part of the intramedullary nail.Although the perforation was treated conservatively using external fixation and the patient¿s progress was monitored, the perforation progressed, so we replaced the intramedullary nail with a long nail and bone union was eventually achieved.".

• Brand Name: UNKNOWN T2 SUPRACONDYLAR NAIL (SCN)
• 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: 14344825
• MDR Text Key: 291394125
• Report Number: 0009610622-2022-00180
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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

• 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
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA 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): Required Intervention