MAUDE Adverse Event Report: Stryker GmbH CONNECTING ROD HOFFMANN II MICRO Ø 3 X 120MM; Appliance, fixation, nail/blade/plate combination, multiple component

Catalog Number	50796120
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "carbon rods show visible cracks after sterilization/cleaning (reprocessing)".
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received products shows that all returned rods are cracked on both ends as reported.Inspection of the received information/evidence are done or will be done, in the proceedings of the nc.Based on investigation, the root cause was attributed to a design related issue.

• Brand Name: CONNECTING ROD HOFFMANN II MICRO Ø 3 X 120MM
• 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: 25321955
• Report Number: 0008031020-2026-00739
• Device Sequence Number: 5368348
• Product Code: KTT
• UDI-Device Identifier: 04546540389947
• UDI-Public: (01)04546540389947(11)210804(10)25865H
• 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: Other Health Care Professional
• 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: Health Professional
• Device Catalogue Number: 50796120
• Device Lot Number: 25865H
• Date Returned to Manufacturer: 07/16/2025
• 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): Yes
• Date Device Manufactured: 08/04/2021
• 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