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

Model Number	2353-3103
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "when drilling into the distal lag screw hole, the drill interfered with the nail and could not be drilled.The proximal lag screw hole could be drilled without any problem, and the lag screw was inserted.In addition, two proximal transverse screws were inserted, and proximal fixation was completed.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.
Additional Manufacturer Narrative
Please note the correction to d3.The reported event could not be confirmed since the device was not returned for evaluation.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.A functional inspection, performed by the operations department in japan, was ¿unable to reproduce the reported event and confirmed that there were no functional problems, so the product will not be returned.¿ it was confirmed the patient had strong osteosclerosis which could have caused deflection of the drill.Investigation results revealed no deficiency with the device.Based on investigation, the root cause was attributed to a patient related issue.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when drilling into the distal lag screw hole, the drill interfered with the nail and could not be drilled.The proximal lag screw hole could be drilled without any problem, and the lag screw was inserted.In addition, two proximal transverse screws were inserted, and proximal fixation was completed.".

• 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: 16852087
• Report Number: 0009610622-2023-00145
• Device Sequence Number: 18054432
• Product Code: HSB
• UDI-Device Identifier: 07613327338652
• UDI-Public: 07613327338652
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203819
• 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): 08/15/2023

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 Model Number: 2353-3103
• Device Catalogue Number: 23533103
• Device Lot Number: KP460635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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: 76 YR
• Patient Sex: Male