MAUDE Adverse Event Report: ARTHREX, INC. SCREWDRIVER, T15 HEXALOBE, CANNULATED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number SCREWDRIVER, T15 HEXALOBE, CANNULATED

Device Problem Flaked (1246)

Patient Problem Insufficient Information (4580)

Event Date 04/23/2021

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

It was reported that during a procedure, the paint was flaking off of the following devices.The flakes were removed from the patient.No patient harm.Ar-8943-09 lot: 1391715, ar-8943-12 lot: 6791217, ar-8943-14 lot: 5262019.

Manufacturer Narrative

Complaint confirmed, the black and yellow coating are chipped.This is the first occurrence for this batch.The cause of the chipping is undetermined.

• Brand Name: SCREWDRIVER, T15 HEXALOBE, CANNULATED
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11799625
• MDR Text Key: 252332324
• Report Number: 1220246-2021-03044
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867052192
• UDI-Public: 00888867052192
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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: SCREWDRIVER, T15 HEXALOBE, CANNULATED
• Device Catalogue Number: AR-8943-09
• Device Lot Number: 1391715
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 04/23/2021
• Supplement Dates FDA Received: 06/03/2021
• Patient Sequence Number: 1