MAUDE Adverse Event Report: ARTHREX INC. FLIPCUTTER II; INSTRUMENT,SURGICAL, DISPOSABLE CUTTER

Catalog Number AR-1204AF-80

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2016

Event Type  malfunction  

Event Description

The disposable cutter device (flipcutter) was damaged during the procedure when the tip of the device broke off.The broken piece, along with the damaged device, and insertion cannula were removed from the surgical site and accounted for.There was no retained object, nor negative impact on the outcome.

• Brand Name: FLIPCUTTER II
• Type of Device: INSTRUMENT,SURGICAL, DISPOSABLE CUTTER
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside blvd.; naples FL 34108
• MDR Report Key: 6510623
• MDR Text Key: 73345378
• Report Number: 6510623
• Device Sequence Number: 0
• Product Code: NBH
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: AR-1204AF-80
• Device Lot Number: 617565494
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19 YR