MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 23533103

Device Problems Fracture (1260); Activation, Positioning or SeparationProblem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2019

Event Type  malfunction  

Manufacturer Narrative

Device was not returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition unknown.

Event Description

It was reported that, during a primary procedure on a right femur, the strike plates with the t2 greater troch system wouldn't thread onto the targeter. Plates were cross threaded. Surgery completed by impacting the bottom of the targeter, which in turn became damaged. Surgical delay of approximately 45 minutes.

• Brand Name: TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8474781
• MDR Text Key: 140955362
• Report Number: 0009610622-2019-00132
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 23533103
• Device Lot Number: KP423047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse