MAUDE Adverse Event Report: STRYKER CORPORATION HUDSON; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	6203113000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
While dr.Was attempting to use the reamer instrument, the regular hudson attachment broke into two pieces.The instrument and hudson piece were then passed off the sterile field.Repair tag applied.

• Brand Name: HUDSON
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER CORPORATION; 1941 stryker way; portage MI 49002
• MDR Report Key: 24775861
• Report Number: 24775861
• Device Sequence Number: 6132697
• Product Code: HWE
• UDI-Device Identifier: 04546540501622
• UDI-Public: (01)04546540501622(10)23073
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026
• Report Date (Section F): 03/30/2026

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 Model Number: 6203113000
• Device Catalogue Number: 6203113000
• Device Lot Number: 23073
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Date Report Sent to FDA: 03/30/2026