MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP HUDSON/MODIFIED TRINKLE ATTACHMENT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	6203135000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was determined to have a fractured tibial plateau, 10 days after a hemi-knee surgery involving this device.The patient will undergo a revision surgery.
Additional Manufacturer Narrative
Updated information: b5; d2; d4.
Event or Problem Description
It was reported that the patient presented 10 days after a hemi-knee procedure with a fractured tibia plateau.The patient underwent a knee revision.The injury appears to result from a multi-factorial event.The injury may be related to the knee replacement itself, as periprosthetic fractures (ppf) can occur due to factors like poorly fitting implants, malalignment, or the patient's condition (e.G., osteoporosis or prior trauma).Additionally, excessive force or tibial resection during the procedure could lead to further fracture or complicate bone quality, particularly in osteoporotic patients, increasing the risk of a periprosthetic fractures.

• Brand Name: HUDSON/MODIFIED TRINKLE ATTACHMENT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20847415
• Report Number: 3015967359-2024-02379
• Device Sequence Number: 3928598
• Product Code: HWE
• UDI-Device Identifier: 04546540501684
• UDI-Public: (01)04546540501684
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 6203135000
• Device Lot Number: 16280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/30/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown