MAUDE Adverse Event Report: STRYKER GMBH FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø11X420MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23311142S
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	05/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported: "patient interaction with a couple of locking screws that were placed in the left femur, which has presented as just really severe itching.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : the device remains implanted in the patient.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and it can not be confirmed with provided medical records.With the available discharge summary and radiograph a formal medical opinion was sought: with the provided information, severe itching in the area of the screws is the only symptom, we can not determine whether this is an allergic reaction.The reaction may still be a material sensitivity, but there is no ample proof of an allergy.The patch testing may also not provide the definitive answer, since the skin reaction is very different from the "in body" internal soft tissue reaction.The required detail regarding metals or a list of the ingredients in the implants, the material composition is provided of material used for implants.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 or Problem Description
It was reported: "patient interaction with a couple of locking screws that were placed in the left femur, which has presented as just really severe itching.".
Additional Manufacturer Narrative
Correction - please refer to h6 device code.
Event or Problem Description
It was reported: "patient interaction with a couple of locking screws that were placed in the left femur, which has presented as just really severe itching.".

• Brand Name: FEMORAL NAIL GT, LEFT T2 ALPHA FEMUR ANTEGRADE Ø11X420MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 19102115
• Report Number: 0009610622-2024-00152
• Device Sequence Number: 15305563
• Product Code: HSB
• UDI-Device Identifier: 07613327284300
• UDI-Public: 07613327284300
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2024

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 23311142S
• Device Lot Number: K0AC003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/31/2024; 11/18/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/26/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 54 YR
• Patient Sex: Male