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 Problems Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 12/12/2014

Event Type  Injury  

Event Description

The manufacturer became aware of a 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, patient information, and currently no additional device information is available.It was reported that 7 patients experienced knee pain, which required implant removal.The report states, ¿in terms of postoperative complications, there were 8 cases in group n where the implant was removed because of knee pain thought to have been caused by a condylar screw.In 3 of these cases, joint mobilization was performed during implant removal because flexion was restricted in the knee.¿ (1 out of the 8 is reported under (b)(4)).

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged knee pain, 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.

Manufacturer Narrative

Correction.The manufacturer became aware of the following medical journal published by the department of orthopedic surgery, anjo kosei hospital, japan, attached to this report.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¿.

Event Description

The manufacturer became aware of a 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, patient information, and currently no additional device information is available.It was reported that 7 patients experienced knee pain, which required implant removal.The report states, ¿in terms of postoperative complications, there were 8 cases in group n where the implant was removed because of knee pain thought to have been caused by a condylar screw.In 3 of these cases, joint mobilization was performed during implant removal because flexion was restricted in the knee.¿ (1 out of the 8 is reported under (b)(4).

• 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: 14345104
• MDR Text Key: 291277131
• Report Number: 0009610622-2022-00182
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 7
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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: 04/20/2022
• Initial Date FDA Received: 05/10/2022
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/08/2024
• 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