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

Model Number	6213147070
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr was notified at 1600 by radiology of retained fragment, patient had already been discharged.Image matches the end of a stryker performance series sagittal blade ref #6118-127-110 lot# 24309017.When the blade broke, the failsafe on the saw should have activated and shut down the saw.Blade was obtained from sharps container, risk notified, stryker rep notified.

• Brand Name: STRYKER PERFORMANCE SERIES
• 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: 21525003
• Report Number: 21525003
• Device Sequence Number: 18531844
• Product Code: HWE
• UDI-Device Identifier: 07613252706601
• UDI-Public: (01)07613252706601
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/31/2025
• Report Date (Section F): 01/31/2025

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
• Device Model Number: 6213147070
• Device Catalogue Number: 6213-147-070
• Device Lot Number: 24309017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2025
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Date Report Sent to FDA: 01/31/2025