MAUDE Adverse Event Report: Stryker GmbH HOFFMANN II CONNECTING ROD MICRO D3 X 40MM; Appliance, fixation, nail/blade/plate combination, multiple component

Catalog Number	50796040
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "carbon rods show small cracks and swelling after the first cleaning/sterilization cycle.".
Additional Manufacturer Narrative
The complaint could be confirmed, due to feedback from other complaints.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.Inspection of the received information/evidences are done or will be done, in the proceedings of the nc.Based on investigation, the root cause was attributed to a desing related issue.

• Brand Name: HOFFMANN II CONNECTING ROD MICRO D3 X 40MM
• 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: 25321716
• Report Number: 0008031020-2026-00733
• Device Sequence Number: 21332773
• Product Code: KTT
• UDI-Device Identifier: 04546540389909
• UDI-Public: 04546540389909
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2026

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: Other
• Device Catalogue Number: 50796040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 08/07/2026
• 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