MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3125-0170S

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

Patient Problem Unspecified Infection (1930)

Event Date 12/22/2021

Event Type  Injury  

Manufacturer Narrative

Device is not accessible.If additional information becomes available, it will be provided in a supplemental report.

Event Description

It was reported that the patient's right femur was revised due to infection.A short gamma femoral nail, lag screw, top locking screw, and distal screw were revised to a cemented total hip.

Event Description

It was reported that the patient's right femur was revised due to infection.A short gamma femoral nail, lag screw, top locking screw, and distal screw were revised to a cemented total hip.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.More detailed information about the complaint event as well as the affected device and patient's information must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø10X170MM 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13282909
• MDR Text Key: 283966817
• Report Number: 0009610622-2022-00023
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375063
• UDI-Public: 04546540375063
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Model Number: 3125-0170S
• Device Catalogue Number: 31250170S
• Device Lot Number: K05B189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/18/2022
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2018
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 69 KG