MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - TARGET DEVICE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13200111
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
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: "when aiming, the k-wire sometimes touches the nail; when drilling, metal contact can be felt.The procedure was completed with the use of a second device.".
Additional Manufacturer Narrative
The reported event that target device gamma3 was alleged of guidance inaccuracy could not be confirmed, since the returned device is conforming to specifications and fully functional.The device inspection revealed the following: the device returned passed simulation of pre-operative function test as intended.Potentially reduced accuracy in guidance is usually found during functional check (required per ifu).In case of any deviation, it is realized prior to use.Pre-supposing that targeting accuracy for drilling was confirmed by pre-operative check it was concluded that the event was mainly based in the intra-operative procedure.Reasons for misaligned drilling are various.Potential miss-targeting can also be caused but is not limited by e.G.Loosening of the nail holding bolt during insertion of the nail.Repeated tightening of the nail holding screw prior to distal targeting / drilling is recommended.Not realized unintended loosening of the attachment knob (will lead to release of the drill sleeve), no use of drill with centre tip / unfavourable bone contour, drilling without drill guiding sleeve, using blunt or damaged drill, high forces applied to the target device during drilling eventually leading to unintended distortion in the system of drill, sleeve, target device and nail.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "when aiming, the k-wire sometimes touches the nail; when drilling, metal contact can be felt.The procedure was completed with the use of a second device.".

• Brand Name: GAMMA3 - TARGET DEVICE
• 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: 23680312
• Report Number: 0008031020-2025-02108
• Device Sequence Number: 18593812
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: 04546540716774
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123401
• 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): 02/24/2026

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: 13200111
• Device Lot Number: KME904200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2012
• 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