MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE ABS BUTTON ROUND 11MM CONCAVE; PIN, FIXATION, SMOOTH

Model Number TIGHTROPE ABS BUTTON ROUND 11MM CONCAVE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/17/2021

Event Type  Injury  

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) 2021, it was reported by sales representative via email that an ar-1588tnt fibertag abs tightrope failed to properly tension down ar-1588tb-3 abs button.This was discovered during an acl reconstruction, surgeon had to use a swivelock to complete case.Additional info requested.

• Brand Name: TIGHTROPE ABS BUTTON ROUND 11MM CONCAVE
• 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: 12615403
• MDR Text Key: 278218412
• Report Number: 1220246-2021-03774
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867157729
• UDI-Public: 00888867157729
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110123
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TIGHTROPE ABS BUTTON ROUND 11MM CONCAVE
• Device Catalogue Number: AR-1588TB-3
• Device Lot Number: 13581746
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Date Device Manufactured: 06/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other