MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAG TIGHTROPE WITH FLIPCUTTER III; PIN, FIXATION, SMOOTH

Model Number FIBERTAG TIGHTROPE WITH FLIPCUTTER III

Device Problems Break (1069); Product Quality Problem (1506)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/01/2022

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

On (b)(6) 2022, it was reported by a sales representative via sems that qty.2 of an ar-1204ff flipcutter iii had an issue.One was included in a 1288qis-100 kit, and a picture of the second one was provided.The proper technique was used and they both shattered.They were able to recover all metal pieces from the patient and there was no negative outcome.This has become a reoccurring issue with the flip cutter 3¿s.This was discovered during use in an unspecified procedure on (b)(6) 2022 with no impact to the patient.Additional information has been requested.On (b)(6) 2022, the sales representative replied via email and stated the following information.This event occurred during an acl reconstruction procedure.One device was an ar-1204ff flipcutter iii, the other device, also an ar-1204ff flipcutter iii, was included in an ar-1288rtt-fc3 fibertag tightrope with flipcutter iii.Both devices were discarded.

• Brand Name: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 15445871
• MDR Text Key: 306004221
• Report Number: 1220246-2022-05505
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867357624
• UDI-Public: 00888867357624
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112990
• 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: 09/19/2022

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: FIBERTAG TIGHTROPE WITH FLIPCUTTER III
• Device Catalogue Number: AR-1288RTT-FC3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1