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

Catalog Number UNK_KIE

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

Patient Problem Implant Pain (4561)

Event Date 12/12/2014

Event Type  Injury  

Event Description

The manufacturer became aware of literature published by the department of orthopedic surgery, anjo kosei hospital, japan.The title of this report is, ¿clinical outcome of surgical treatment for distal femoral fracture with locking plate and intramedullary retrograde nail ¿, published on december 12, 2014, which is associated with the stryker ¿t2 supracondylar nailing system¿.The article can be found at https://doi.Org/10.11359/chubu.2014.1101.This report includes an analysis of the clinical data that was collected on 27 patients, and the cases in this study range from may 2005 to july 2012.During the review of the literature, it was not possible to establish a specific device detail and patient information, and currently, no additional device information is available.It was reported that 1 patient experienced pain around the medial condyle, which required implant removal.The report states, ¿(b)(6) female.The patient sustained an ao classification type c1 distal femoral fracture in a fall.Osteosynthesis using the t2scn was performed under lumbar anesthesia 7 days after injury.Full weight-bearing ambulation was started 50 days after surgery.Although the bone union was achieved, the implant was removed 1 year after surgery due to pain around the medial condyle thought to have been caused by a condylar screw.After implant removal, the pain improved.¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged pain around the medial condyle, which required implant removal, 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 literature published by the department of orthopedic surgery, anjo kosei hospital, japan.The title of this report is, ¿clinical outcome of surgical treatment for distal femoral fracture with locking plate and intramedullary retrograde nail ¿, published on december 12, 2014, which is associated with the stryker ¿t2 supracondylar nailing system¿.The article can be found at https://doi.Org/10.11359/chubu.2014.1101.This report includes an analysis of the clinical data that was collected on 27 patients, and the cases in this study range from may 2005 to july 2012.During the review of the literature, it was not possible to establish a specific device detail and patient information, and currently, no additional device information is available.It was reported that 1 patient experienced pain around the medial condyle, which required implant removal.The report states, ¿56-year-old female.The patient sustained an ao classification type c1 distal femoral fracture in a fall.Osteosynthesis using the t2scn was performed under lumbar anesthesia 7 days after injury.Full weight-bearing ambulation was started 50 days after surgery.Although the bone union was achieved, the implant was removed 1 year after surgery due to pain around the medial condyle thought to have been caused by a condylar screw.After implant removal, the pain improved.¿.

Manufacturer Narrative

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 pain around the medial condyle, which required implant removal could not be confirmed, since soft tissue irritation cannot be seen on the x-ray, even if the quality is perfect.Based on the available information and x-ray, a formal medical opinion was requested and states: "that there can be soft tissue irritation problem around the knee joint.However, this can be better assessed by a detailed clinical evaluation and a sound investigation including a physical examination.Therefore the x-ray is probably not the key instrument to assess this, the clinical examination is way more important.The complication would be regarded as surgical technique related and neither related to the patient, nor the implant".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 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: 14345106
• MDR Text Key: 291287099
• Report Number: 0009610622-2022-00183
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• 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: 06/02/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Female