MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL PF, LEFT T2 ALPHA FEMUR ANTEGRADE Ø12X380MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 2335-1238S

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

Patient Problems Non-union Bone Fracture (2369); Impaired Healing (2378)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available. More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event. The device history record could not be reviewed because the affected lot number was not communicated. If any further information is provided, the investigation report will be updated.

Event Description

The manufacturer became aware of a post market clinical follow-up report received from (b)(6), in usa. The title of this report is ¿a retrospective data collection of the treatment of femoral fractures with the femoral nail piriformis fossa (pf) of the t2 alpha femur antegrade gt/pf nailing system¿ which is associated with the stryker ¿t2 alpha femur antegrade gt/pf nailing system¿. This study includes research done on 18 patients (19 cases) requiring surgery between the period march 2019 and october 2019. It was not possible to ascertain specific device details from the report, or to match the events reported with previously reported complaints. Therefore, new complaint was initiated in the system for the post-operative complication mentioned in the report. This product inquiry addresses delayed union. The report states: ¿the 2nd patient with delayed union occurred 105 days after the initial surgery, is ongoing, and a low power electromagnetic osteogenic stimulator device was prescribed. The patient is a (b)(6) years old female, smoker, diabetic, and has a history of hypothyroidism, and rheumatoid arthritis. She had a standing fall, and she was admitted to the hospital with a closed left femur fracture classified as 32-b1. The device utilized for the surgical procedure was 12x380 t2 alpha femoral nail pf, and had proximal static oblique locking mode. This patient is continuing to be followed and will be included within the final study report. ¿.

• Brand Name: FEMORAL NAIL PF, LEFT T2 ALPHA FEMUR ANTEGRADE Ø12X380MM
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 10538483
• MDR Text Key: 207215558
• Report Number: 0009610622-2020-00511
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 2335-1238S
• Device Catalogue Number: 23351238S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• 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: 09/15/2020 Patient Sequence Number: 1