MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X115MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3060-0115S

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

Patient Problems Abscess (1690); Necrosis (1971); Osteomyelitis (4533)

Event Date 11/24/2022

Event Type  Injury  

Manufacturer Narrative

The received x-ray was reviewed and the reported necrosis can be confirmed.Only based on this picture it is not possible to determine if the necrosis is in relation with the implants, especially as the devices were implanted for more than 3 years.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

As reported: "i take care of a patient after osteosynthesis of the right femur.The operation was carried out in (b)(6) 2019.The patient came to our department for femoral head necrosis with osteomyelitis and soft tissue abscess of the thigh.We need to extract the implants.This is a stryker 3 gamma nail system.The operation is scheduled for (b)(6) 2022.".

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X115MM
• 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: 16496486
• MDR Text Key: 310807082
• Report Number: 0009610622-2023-00076
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540374974
• UDI-Public: 04546540374974
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K200869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2022
• Device Model Number: 3060-0115S
• Device Catalogue Number: 30600115S
• Device Lot Number: K0A4C5D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2017
• 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: 53
• Patient Sex: Male