MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM DRILL BIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 3.0MM DRILL BIT

Device Problem Fitting Problem (2183)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

During returned device evaluation, a reportable malfunction was discovered.Complaint confirmed, evaluation reveals approximately.57 in of the flute broke off.Relevant features and material were found to meet drawing specifications.Abrasion marks were observed on the flute.A likely cause of the breakage is prying/leveraging the device during use.

Event Description

It was reported that during an inverse prosthesis surgery the device didn`t fit into the drill guide.No part of the device broke off.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.During returned device evaluation, a reportable malfunction was discovered.

• Brand Name: 3.0MM DRILL BIT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 12770119
• MDR Text Key: 283955137
• Report Number: 1220246-2021-03880
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3.0MM DRILL BIT
• Device Catalogue Number: AR-9628
• Device Lot Number: 021951
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/26/2019
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1