MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN T2SCN 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 07/01/2015

Event Type  Injury  

Manufacturer Narrative

This record is a consolidation of events summarized as part of literature review, when device and patient information is not available. This complaint has been generated based on findings discovered during post market surveillance literature review. The alleged 37 patients that experienced non-union as mentioned in the literature 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 a literature published by department of orthopaedic surgery, saiseikai senri hospital, japan. The title of this report is ¿treatment of distal femoral fractures using retrograde femoral nails in elderly patients¿ published on july 1 2015, which is associated with the stryker t2scn system. The article can be found at https://doi. Org/10. 11359/chubu. 2012. 1409. This report includes analysis of the clinical data that was collected on 57 patients, the cases in this study range from april 2009 and october 2014. During the review of the literature, it was not possible to establish specific device details, patient information, and at this time no additional device information is available. It was reported that 37 patients experienced non-union.

• Brand Name: UNKNOWN T2SCN 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: 13691146
• MDR Text Key: 288356187
• Report Number: 0009610622-2022-00083
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 37
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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: 02/09/2022
• 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 Treatment Data

Date Received: 03/08/2022 Patient Sequence Number: 1