MAUDE Adverse Event Report: Stryker GmbH Hoffmann II Connecting Rod Micro D3 x 50mm; Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Catalog Number	50796050
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction

• Brand Name: Hoffmann II Connecting Rod Micro D3 x 50mm
• Common Device Name: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
• 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: 50418731
• Report Number: 0008031020-2026-01305
• Device Sequence Number: 16097847
• Product Code: KTT
• UDI-Device Identifier: 04546540389916
• UDI-Public: 04546540389916
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2026

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: 50796050
• Device Lot Number: unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2827-2026
• Patient Sequence Number: 1
• Patient Sex: Unknown