MAUDE Adverse Event Report: ARTHREX, INC. FLX REAMER & TIGHTROPE DRILL PIN 9.0MM; BIT, SURGICAL

Model Number FLX REAMER & TIGHTROPE DRILL PIN 9.0MM

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/09/2022

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 an ar-1401f-9 flexible reamer broke during a procedure.Additional information received on (b)(6) 2022: this was discovered during an aclr procedure on (b)(6) 2022 and was completed using another ar-1401f-9 flexible reamer.The device broke while drilling the femoral tunnel and all the broken fragments were retrieved from inside the patient.

• Brand Name: FLX REAMER & TIGHTROPE DRILL PIN 9.0MM
• Type of Device: BIT, SURGICAL
• 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: 14829035
• MDR Text Key: 301637102
• Report Number: 1220246-2022-05141
• Device Sequence Number: 1
• Product Code: GFG
• 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: 06/27/2022

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 Expiration Date: 11/30/2022
• Device Model Number: FLX REAMER & TIGHTROPE DRILL PIN 9.0MM
• Device Catalogue Number: AR-1401F-90
• Device Lot Number: 18E61
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 06/27/2022
• Date Device Manufactured: 05/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1