MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC STRYKER PERFORMANCE SERIES SAGITTAL BLADE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number 6221-127-090

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/06/2017

Event Type  malfunction  

Event Description

Doctor was doing a total knee arthroplasty when he turned around and said that the blade that he was using was not sharp and that he felt that it was a refurbished blade.The doctor was given a new sharp blade.

• Brand Name: STRYKER PERFORMANCE SERIES SAGITTAL BLADE
• Type of Device: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 6961180
• MDR Text Key: 89710839
• Report Number: 6961180
• Device Sequence Number: 0
• Product Code: HSZ
• 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: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 6221-127-090
• Device Lot Number: 17083017
• Other Device ID Number: 6221-127-700 REV-C
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR