MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC FORMULA AGGRESSIVE PLUS CUTTER (RED/BLUE); ARTHROSCOPE

Catalog Number 375-544-000

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/15/2017

Event Type  malfunction  

Event Description

During procedure shaver disengaged and the teeth broke off into knee.Broken teeth of shaver were removed without difficulty per dr.

• Brand Name: FORMULA AGGRESSIVE PLUS CUTTER (RED/BLUE)
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC; 5300 region ct; lakeland FL 33815
• MDR Report Key: 6398567
• MDR Text Key: 69757501
• Report Number: 6398567
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2017,03/08/2017

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: Physician
• Device Catalogue Number: 375-544-000
• Device Lot Number: 5491151
• Other Device ID Number: 4MM
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 119