MAUDE Adverse Event Report: STRYKER CORPORATION THE MILL DISPOSABLE - MEDIUM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number 5400-701-000

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 10/08/2020

Event Type  malfunction  

Event Description

While attempting to insert bone graft, surgeon noticed piece of what appeared to be plastic or glass in the bone graft material.After further inspection, the team determined 2 parts of the disposable stryker bone mill were chipped, and it appeared that it matched the piece found.The piece was removed, and the rest of the bone graft was inspected before placing it into the patient's spine.Type of surgery: lumbar 4 - pelvis instrumentation and fusion, lumbar 4-sacral laminectomy.

• Brand Name: THE MILL DISPOSABLE - MEDIUM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 12106550
• MDR Text Key: 259615390
• Report Number: 12106550
• Device Sequence Number: 1
• Product Code: HWE
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5400-701-000
• Device Catalogue Number: 5400-701-000
• Device Lot Number: 20078012
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA