MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT; INSTRUMENT, SURGICAL ORTHOPEDIC AC-POWERED MOTOR AND ACCESSORY ATTACHMENT

Model Number AR-1204AS-100

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2019

Event Type  malfunction  

Event Description

Pt in surgery for knee arthroscopically-aided anterior cruciate ligament reconstruction surgery.An arthrex flipcutter ii, short, was being utilized, and it was identified that the end of the device would not flip.Device removed from the field.Add'l instrument opened for the procedure.No pt harm.Fda safety report id# (b)(4).

• Brand Name: FLIPCUTTER II, SHORT
• Type of Device: INSTRUMENT, SURGICAL ORTHOPEDIC AC-POWERED MOTOR AND ACCESSORY ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 9128810
• MDR Text Key: 160519452
• Report Number: MW5090073
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: AR-1204AS-100
• Device Catalogue Number: AR-1204AS-100
• Device Lot Number: 917895006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 93