MAUDE Adverse Event Report: STRYKER GMBH DTD FEMUR RETROGRADE T2 ALPHA FEMUR RETROGRADE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23533907
Medical Device Problem Codes	Difficult to Remove (1528); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
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: "when removing the distal and proximal devices after surgery, they were firmly fixed and could not be removed manually, so dr.Tried to remove them by hitting them with a hammer and damaged them".
Additional Manufacturer Narrative
The reported event of jamming of devices could not be confirmed, since the returned device was found to be functional with respect to alleged issue, however the buttons were broken from the device due to external impact.The device inspection revealed the following: the target device was received with three knobs/button on one side broken and detached from the individual connection point on the underside of the device.The breakage appears to be brittle in nature caused by a sudden high impact.Overall, the device showed normal signs of usage and free from any other damage.A functional test was performed with the returned target device and a sample nail adapter.Upon fitment, it was observed that the nail adapter could easily be slid into the target device and removed as well.The knob was also functioning properly.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for cleaning, sterilization, inspection & maintenance instructs the user about preventive maintenance: use an appropriate instrument spray for the mechanism of all moving parts and articulating surfaces.Handle with care.Do not hit on target devices.In case of failure, the instrument must be replaced and not be used [original statement(s)].Based on the above investigation, the root cause of the issue is deemed to be user related.The target device could easily be assembled and disassembled without any issue.However, the breakage of buttons due to external hitting renders the device not fit for use.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when removing the distal and proximal devices after surgery, they were firmly fixed and could not be removed manually, so dr.Tried to remove them by hitting them with a hammer and damaged them".

• Brand Name: DTD FEMUR RETROGRADE T2 ALPHA FEMUR RETROGRADE
• 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: 20766494
• Report Number: 0009610622-2024-00923
• Device Sequence Number: 9446628
• Product Code: HSB
• UDI-Device Identifier: 07613327411843
• UDI-Public: (01)07613327411843(11)220620(10)K0E9654
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: 23533907
• Device Lot Number: KP474981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 11/23/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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 Sex: Unknown