MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A; BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL

Model Number	2108-151
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Stryker saw blade "prong" broke while being used.

• Brand Name: N/A
• Common Device Name: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5900 optical ct.; san jose CA 95138
• MDR Report Key: 19114901
• Report Number: 19114901
• Device Sequence Number: 15238999
• Product Code: GFA
• UDI-Device Identifier: 00885825012175
• UDI-Public: (01)00885825012175
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 01/18/2024
• Report Date (Section F): 01/18/2024

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: 2108-151
• Device Catalogue Number: 2108-151
• 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: 04/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/18/2024