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	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "target drilling holes are not centered in the fixtures.Replacement was available.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.

• 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 GMBH; 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: 24715584
• Report Number: 0008031020-2026-00497
• Device Sequence Number: 14868948
• Product Code: HSB
• UDI-Device Identifier: 04546540716774
• UDI-Public: (01)04546540716774(11)200416(10)K070E47
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: KME914946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2020
• 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