MAUDE Adverse Event Report: ORTHOFIX INC. OSCAR 3; SYSTEM, CEMENT REMOVAL EXTRACTION

Catalog Number LAO6734 ISS:01

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/17/2016

Event Type  malfunction  

Event Description

The tip of the oscar became engaged in the distal most portion of the cement and fractured.Attempt to retrieve the tip of the oscar and cement plug was unsuccessful and was therefore abandoned.

• Brand Name: OSCAR 3
• Type of Device: SYSTEM, CEMENT REMOVAL EXTRACTION
• Manufacturer (Section D): ORTHOFIX INC.; christopher hack; 3451 plano parkway; lewisville TX 75056
• MDR Report Key: 6266006
• MDR Text Key: 65373376
• Report Number: 6266006
• Device Sequence Number: 1
• Product Code: LZV
• 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: 01/10/2017

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: No Information
• Device Catalogue Number: LAO6734 ISS:01
• Device Lot Number: WO/22724/A
• Other Device ID Number: 1 OMM PEIRCER PROBE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR