MAUDE Adverse Event Report: STRYKER INSTRUMENTS FORMULA; BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL

Model Number	0375552000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When in central supply gathering supplies this unopened shaver blade was placed in a cart.It was observed inside the unopened sterile packaging an unidentified loose material inside the package.

• Brand Name: FORMULA
• Common Device Name: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS; 1941 stryker way; portage MI 49002
• MDR Report Key: 19739622
• Report Number: 19739622
• Device Sequence Number: 11672877
• Product Code: GFA
• UDI-Device Identifier: 07613327061956
• UDI-Public: (01)07613327061956(17)241209(10)19345CE2
• 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): 03/26/2024
• Report Date (Section F): 03/26/2024

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
• Device Model Number: 0375552000
• Device Catalogue Number: 0375-552-000
• Device Lot Number: 19345CE2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2024
• 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 Sex: Unknown
• Date Report Sent to FDA: 03/26/2024