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

Catalog Number REF 0375-545-000

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/06/2017

Event Type  malfunction  

Event 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
• Type of Device: ARTHROSCOPE SHAVER BLADE
• Manufacturer (Section D): STRYKER ENDOSCOPY; 5900 optical court ; san jose CA 95138
• MDR Report Key: 6575492
• MDR Text Key: 75522004
• Report Number: MW5069828
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 07613327061796
• UDI-Public: (01)07613327061796
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: REF 0375-545-000
• Device Lot Number: 16298CE2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 77