MAUDE Adverse Event Report: STRYKER ENDOSCOPY FORMULA TOMCAT CUTTER 4.0MM X 125 MM; ARTHROSCOPE SHAVER BLADE

Catalog Number	REF 0375-545-000
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/06/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Patient having arthroscopy procedure; cutter was being used to shave cartilage when the tip of the device broke off in patient's shoulder.Broken tip was successfully retrieved by surgeon.

• Brand Name: FORMULA TOMCAT CUTTER 4.0MM X 125 MM
• Common Device Name: ARTHROSCOPE SHAVER BLADE
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical court ; san jose CA 95138
• MDR Report Key: 6575492
• Report Number: MW5069828
• Device Sequence Number: 82048
• Product Code: HRX
• UDI-Device Identifier: 07613327061796
• UDI-Public: (01)07613327061796
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/16/2017

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 Catalogue Number: REF 0375-545-000
• Device Lot Number: 16298CE2
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 77