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	07/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "cracks identified in hoffmann micro carbon rods.".
Additional Manufacturer Narrative
Based on the investigation, the root cause was attributed to a design-related issue.This is a confirmed design issue and has already been investigated under an nc, and a capa has been initiated for further action.Based on the information reviewed to date, we reserve the right to conclude that no further investigation is necessary.Based on the aforementioned information, a dhr review was not considered necessary, since the root cause of the event affects all lots in the market.In addition, a device evaluation was not deemed necessary, as similar devices have already been inspected and tested within the scope of the nc.

• 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: 50476591
• Report Number: 0008031020-2026-01371
• Device Sequence Number: 10234022
• Product Code: KTT
• UDI-Device Identifier: 04546540389916
• UDI-Public: 04546540389916
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K033476
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 50796050
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/27/2026
• 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