MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 125 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 34250260S

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Hip Fracture (2349)

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

As reported: "after tha surgery (right side), cutout of a lag screw occurred at the femoral head. After that, the lag screw invaded the pelvis. The initial surgery performed on (b)(6) 2021, the event was confirmed on (b)(6) 2021. The re-operation was performed on (b)(6) 2021. Additional information received on 17-feb-"202": "at the time of the initial operation, the operation was completed without inserting the u blade of the u lag screw and the end cap for the lag screw. In addition, it has been confirmed that the lag screw did not turn when the set screw was not loosened in the removal process. So, the surgeon recognized that the set screw was fixed to some extent. ".

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3 10X260MM X 125
• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11440175
• MDR Text Key: 238589718
• Report Number: 0009610622-2021-00334
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K034002
• 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: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 34250260S
• Device Lot Number: K06EC7E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2020
• 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: 03/08/2021 Patient Sequence Number: 1