MAUDE Adverse Event Report: ARTHREX, INC. AIMING GUIDE, RT, STD, VOLAR DRP; MANUAL INSTR, GENERAL SURGICAL

Model Number AIMING GUIDE, RT, STD, VOLAR DRP

Device Problem Break (1069)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, it was reported by a sales representative via (b)(4) that an ar-8916-01 aiming guide broke.This occurred during a case, with no patient effect reported.There was no additional information provided, additional information has been requested.

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.

• Brand Name: AIMING GUIDE, RT, STD, VOLAR DRP
• Type of Device: MANUAL INSTR, GENERAL 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: 18049040
• MDR Text Key: 327722427
• Report Number: 1220246-2023-08502
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867130012
• UDI-Public: 00888867130012
• 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: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AIMING GUIDE, RT, STD, VOLAR DRP
• Device Catalogue Number: AR-8916-01
• Device Lot Number: 5262041
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1