MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS, INC. MICRO PRECISION SAW BLADE THIN OSCILLATING & SAGITTAL; BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/14/2020

Event Type  malfunction  

Event Description

During a right total knee arthroplasty, portion of micro saw blade broke while in use; xray at end of case per policy if broke portion not located.

• Brand Name: MICRO PRECISION SAW BLADE THIN OSCILLATING & SAGITTAL
• Type of Device: BLADE, SAW, GENERAL PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 west drake drive; tempe AZ 85283
• MDR Report Key: 10717515
• MDR Text Key: 212530528
• Report Number: 10717515
• Device Sequence Number: 1
• Product Code: GFA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: 2296-3-125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2020
• Date Report to Manufacturer: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA