MAUDE Adverse Event Report: ARTHREX, INC. FLX REAMER & TIGHTROPE DRILL PIN 10.0MM; BIT, SURGICAL

Model Number FLX REAMER & TIGHTROPE DRILL PIN 10.0MM

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.

Event Description

On (b)(6) 2023, it was reported by a sales representative via sems that the tip of the drill pin from an ar-1401f-100 flexible reamer with flexible tightrope drill pin broke off inside the bone during drilling.All the broken fragments were retrieved.This was discovered during an acl procedure on (b)(6) 2023.The procedure was completed successfully without further issues.Additional information requested.

• Brand Name: FLX REAMER & TIGHTROPE DRILL PIN 10.0MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 17190752
• MDR Text Key: 317784505
• Report Number: 1220246-2023-06972
• 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: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLX REAMER & TIGHTROPE DRILL PIN 10.0MM
• Device Catalogue Number: AR-1401F-100
• Device Lot Number: 23C110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2023
• Date Device Manufactured: 03/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1