MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X180MM X 130DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31301180S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "the target device cannot be detached from the implant.The nail was completely implanted, including proximal and distal locking.The target bar could no longer be disconnected via the nail retaining screw, so an attempt was made to remove the distal locking.However, the target bar was in the way, so an attempt was made to shorten it using a saw.Ultimately, the bar and nail were removed using a hammer.Replacement was available.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the returned devices were stuck as described in the event description.The device inspection revealed the following: the nail including set screw, the target device and the holding screw were returned in assembled condition.The reported cutting with a saw of the targeting device can be confirmed as the device is cut apart.At the lag screw and the locking screw hole are strong missdrilling marks visible.These damages may be a sign that the construct was under tension after the screws were inserted.The devices could be disassembled during the investigation by using an allen key in combination with a lever.This increased effort required to loosen the screw confirms the complaint.After the loosening some reddish residues at the thread of the nail holding screw were detected.In retrospect, it cannot be determined how these residues got onto the thread, as the device is normally assembled outside the patient.The inspection of the nail interface at the targeting arm has shown that the interface is in a very used condition, especially the holding ring is totally worn.After the disassembly the devices were decontaminated again and after that a functional test was performed.The devices could be assembled and disassembled with no issue.The complained malfunction could not be reproduced.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.No product related issue could be detected during the investigation.Most likely did a combination between different factors, like overtightening, too much pressure on the construct, residues on the thread and wear, lead to the reported event.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "the target device cannot be detached from the implant.The nail was completely implanted, including proximal and distal locking.The target bar could no longer be disconnected via the nail retaining screw, so an attempt was made to remove the distal locking.However, the target bar was in the way, so an attempt was made to shorten it using a saw.Ultimately, the bar and nail were removed using a hammer.Replacement was available.".

• Brand Name: GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X180MM X 130DEG
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23839381
• Report Number: 0008031020-2025-02185
• Device Sequence Number: 9958354
• Product Code: HSB
• UDI-Device Identifier: 04546540375124
• UDI-Public: (01)04546540375124(17)300531(10)K12B731
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• 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): 03/24/2026

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: 31301180S
• Device Lot Number: K12B731
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2025
• 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
• Patient Age: 73 YR
• Patient Sex: Male