MAUDE Adverse Event Report: Stryker GmbH GAMMA4 - INTERMEDIATE TARGETING SLEEVE; Rod, Fixation, Intramedullary And Accessories

Catalog Number	14202100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: "the gamma4 targeter has continuously been missing the distal screws of the nail on intermediate nails.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.

• Brand Name: GAMMA4 - INTERMEDIATE TARGETING SLEEVE
• Common Device Name: Rod, Fixation, Intramedullary And Accessories
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 25255471
• Report Number: 0008031020-2026-00681
• Device Sequence Number: 5418286
• Product Code: HSB
• UDI-Device Identifier: 07613327591477
• UDI-Public: 07613327591477
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: 14202100
• Device Lot Number: KP505180
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/20/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 08/12/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2024
• 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 Sex: Unknown