MAUDE Adverse Event Report: ARTHREX, INC. FLIPCUTTER II, SHORT 10.5MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number FLIPCUTTER II, SHORT 10.5MM

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported during a acl reconstruction procedure, the tip of the ar-1204as-105 fipcutter broke as the surgeon was making the tunnel.All fragments were fully retrieved.A second filpcutter was opened and used to complete the procedure without further issue.

• Brand Name: FLIPCUTTER II, SHORT 10.5MM
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 11841580
• MDR Text Key: 254814901
• Report Number: 1220246-2021-03095
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867004290
• UDI-Public: 00888867004290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 05/18/2021

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: Health Professional
• Device Model Number: FLIPCUTTER II, SHORT 10.5MM
• Device Catalogue Number: AR-1204AS-105
• Device Lot Number: 710273111
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1