MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN 10*320 T2 ALPHA FEMORAL NAIL PF LEFT; 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 12/13/2021

Event Type  Injury  

Manufacturer Narrative

This complaint has been generated based on findings discovered during post market surveillance pmcf study review.The alleged nonunion for which revision surgery is scheduled included in the study could not be confirmed, since the device was not returned for evaluation and no other additional information will be made available.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 is unknown.

Event Description

The manufacturer became aware of a pmcf final study report that was conducted by university of louisville in the usa.The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail greater trochanter (pf) of the t2 alpha femur antegrade gt/pf nailing, which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing¿ system.This report includes analysis of the clinical data that was collected on 28 patients, the cases in this study range from march 2019 through august 2020.During the review of the literature, it was not possible to establish a specific device details, patient information, and at this time no additional device information is available.It was reported that one patient experienced nonunion for which revision surgery is scheduled.The report states: ¿patient j (1 device related event): the 4th nonunion case was (b)(6) year old female, bmi (b)(6), nonsmoker, with history of alcohol use.Her injury was due to mva and was classified as closed 32-c3 fracture.The devise used for the initial fixation surgery was 10*320 t2 alpha femoral nail pf left, with recon locking mode.The nonunion was diagnosed 380 days post initial surgery and was advised a revision surgery and will be scheduled for repair of nonunion.¿.

• 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: 13266265
• MDR Text Key: 284901095
• Report Number: 0009610622-2022-00020
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2022
• 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: 12/19/2021
• 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: 49 YR
• Patient Sex: Female