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 Problem Non-union Bone Fracture (2369)

Event Date 05/25/2016

Event Type  Injury  

Event Description

The manufacturer became aware of a literature published by the ¿bg trauma hospital hamburg, germany¿.The title of this report is, ¿an electronically instrumented internal fixator for the assessment of bone healing¿, published on may 25, 2016, which is associated with the stryker ¿t2 femoral nailing system¿.The article can be found at https://doi.Org/10.1302/2046-3758.55.2000611.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 nonunion after dynamization, requiring revision.The report states, ¿ a 33-year-old patient was treated with the instrumented internal fixator for a nonunion 15 months after primary osteosynthesis with a t2 femoral nail and 12 months after dynamization ¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance literature review.The alleged 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.Device disposition unknown.

Event Description

The manufacturer became aware of a literature published by the ¿bg trauma hospital hamburg, germany¿.The title of this report is, ¿an electronically instrumented internal fixator for the assessment of bone healing¿, published on may 25, 2016, which is associated with the stryker ¿t2 femoral nailing system¿.The article can be found at https://doi.Org/10.1302/2046-3758.55.2000611.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 nonunion after dynamization, requiring revision.The report states, ¿ a 33-year-old patient was treated with the instrumented internal fixator for a nonunion 15 months after primary osteosynthesis with a t2 femoral nail and 12 months after dynamization ¿.

Manufacturer Narrative

This complaint has been generated based on findings discovered during the post-market surveillance literature review.The alleged event of nonunion after dynamization, requiring revision, could be confirmed from the available information and x-ray in the literature study.A single-plane x-ray was provided which was not sufficient to make a sound statement, but a formal medical opinion was sought from which it can be determined that the current age of the patient is a typical age for a high impact/velocity trauma leading to complex fracture patterns.There are no obvious mistakes that can be detected from the x-ray.It appears as if the patient was treated well.This statement must be given with the limitation that there is only one x-ray plane available after the initial operation and the dynamization.The context of the fracture is unknown and there is no medical history of the patient or any further information available.Hence, there is no obvious root cause for the event while a cause could potentially be detected with additional clinical information (maybe soft tissue involvement, or comorbidities (although not very likely regarding the young age of the patient).More detailed information about the patients as well as the affected device must be available in order to determine the root cause of the complaint event.If any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.

• 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: 14986822
• MDR Text Key: 295691525
• Report Number: 0009610622-2022-00326
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• 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: 06/21/2022
• 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: 33 YR