MAUDE Adverse Event Report: TORNIER, INC. UNKNOWN; REAMER

Model Number 9027893

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/19/2017

Event Type  malfunction  

Event Description

During a shoulder arthroplasty, strands of metal came off a reamer.All parts were collected.An x-ray was taken.The radiologist confirmed a negative report.

• Brand Name: UNKNOWN
• Type of Device: REAMER
• Manufacturer (Section D): TORNIER, INC.; 100 capital dr.; suite 201; warsaw IN 46582
• MDR Report Key: 6356057
• MDR Text Key: 68228899
• Report Number: 6356057
• Device Sequence Number: 1
• Product Code: HTO
• 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: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 9027893
• Device Lot Number: CEO116118
• Other Device ID Number: SIZE 53
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2017
• 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: 91