MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM X 125° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3125-1200S

Device Problems Break (1069); Fracture (1260)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Ambulation Difficulties (2544); Implant Pain (4561)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The husband of a patient reported the following: "i am referring to the previous correspondence ((b)(4)) which in summary stated that after an operation, on my wife's left femur, she had begun to suffer from atopic dermatitis. Intervention on (b)(6) 2019 performed at the (b)(6) hospital. Subsequently, the fact that from the metal tests done to my wife, she was not allergic to titanium or the material of the nail, from a certain point of view calmed me, but then after a year ((b)(6) 2021) the nail broke. From asst (b)(6) hospital report i read: "x-ray: unconsolidated existence of pertrochanteric fracture with reverse rim and fatigue fracture of the femoral nail at the level of the cephalic screw. " the patient also reported pain.

Manufacturer Narrative

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

Event Description

The husband of a patient reported the following: "i am referring to the previous correspondence ((b)(4)) which in summary stated that after an operation, on my wife's left femur, she had begun to suffer from atopic dermatitis. Intervention on (b)(6) 2019 performed at the (b)(6) hospital. Subsequently, the fact that from the metal tests done to my wife, she was not allergic to titanium or the material of the nail, from a certain point of view calmed me, but then after a year ((b)(6) 2021) the nail broke. From asst (b)(6) hospital report i read: "x-ray: unconsolidated existence of pertrochanteric fracture with reverse rim and fatigue fracture of the femoral nail at the level of the cephalic screw. " the patient also reported pain.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3® Ø11X200MM 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13560494
• MDR Text Key: 285955481
• Report Number: 0009610622-2022-00062
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 3125-1200S
• Device Catalogue Number: 31251200S
• Device Lot Number: K087643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2019
• 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: 02/18/2022 Patient Sequence Number: 1