MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2 FEMORAL NAIL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number UNK_KIE

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

Patient Problems Ambulation Difficulties (2544); Malunion of Bone (4529); Implant Pain (4561)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged pain and rotational malunion, 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 the ¿arthroscopic surgery unit, hospital vithas san jose, spain¿.The title of this report is, ¿application of 3d technology and printing for femoral derotation osteotomy: case and technical report¿, published on october 01, 2017, which is associated with the stryker ¿t2 femoral nailing system¿.The article can be found at http://dx.Doi.Org/10.21037/atm.2017.07.03.This report includes an analysis of the clinical data that was collected on 1 patient.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 left hip pain and rotational malunion, which required revision.The report states, ¿nine months after surgery, the patient was introduced to our clinic for second opinion complaining of pain in his left hip and difficulty walking.We recognized evident ¿in-toe¿ walking with patellofemoral and groin pain.Clinical examination revealed an increase in internal rotation to 90° with reduced external rotation to 10°.Radiological examination revealed fracture consolidation with signs of femoral malrotation.Suspecting a rotational malunion, the study was completed with a computed tomography (ct) in order to measure her femoral anteversion.¿.

• Brand Name: UNKNOWN T2 FEMORAL 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: 14599646
• MDR Text Key: 293335840
• Report Number: 0009610622-2022-00220
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2022

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: 05/11/2022
• Initial Date FDA Received: 06/05/2022
• 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