MAUDE Adverse Event Report: STRYKER GMBH TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23533103
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the sleeve did not pass through the oblique hole in the targeting arm femur gt.The button was pushed but the sleeve did not go through.Hammering the sleeve while pressing the button only advanced it a little.When pulling out the sleeve, it could not be manually pulled out; the sleeve had to be clamped with pliers and beaten out with a hammer.Finally, the screw could not be inserted into the hole where it should be inserted".
Additional Manufacturer Narrative
The reported event could be confirmed, since during functional inspection, abnormal resistance was felt when pulling and pushing the sleeve inside the most proximal hole of the targeting arm.The device inspection revealed the following: the examination of the arm revealed obvious signs of damage around the most proximal hole at the underneath side.This most likely comes from handling of the device during previous uses.However, it did not modify the hole geometry (according to an additional dimensional inspection) and therefore did not contribute to the event.The sleeve could be inserted trough the most proximal hole.However, it did not pass easily through the hole as intended.Efforts were necessary to insert and remove the sleeve from the hole; abnormal resistance was felt.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.The root cause of the event remains undetermined, since the inspection revealed the targeting arm dimensions are confirming to specifications.It cannot be excluded that damage to the inside mechanism (button) could have contributed to the event.However, it would required destructive testing and therefore cannot be performed.As a reminder, the instructions for use state the following: before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.During the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the sleeve did not pass through the oblique hole in the targeting arm femur gt.The button was pushed but the sleeve did not go through.Hammering the sleeve while pressing the button only advanced it a little.When pulling out the sleeve, it could not be manually pulled out; the sleeve had to be clamped with pliers and beaten out with a hammer.Finally, the screw could not be inserted into the hole where it should be inserted".

• Brand Name: TARGETING ARM FEMUR GT T2 ALPHA FEMUR ANTEGRADE
• 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: 20860312
• Report Number: 0009610622-2024-00944
• Device Sequence Number: 3918433
• Product Code: HSB
• UDI-Device Identifier: 07613327338652
• UDI-Public: 07613327338652
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 23533103
• Device Lot Number: KP504333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 63 KG