MAUDE Adverse Event Report: ARTHREX, INC. BROACH, PEGGED GLENOID; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number BROACH, PEGGED GLENOID

Device Problems Break (1069); Dull, Blunt (2407); Material Twisted/Bent (2981)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 10/24/2022

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2022 by a sales representative via sems that an ar-9233, ar-9211 and ar-9239 devices were damaged during use.During case the straight shaft reamer is bent which caused an issue when drilling with 4.5 drill bit.4.5 drill bit was extremely dull.Impactor broke while impacting for vaultlock.This was discovered during a case and broke inside the joint space.

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.

Manufacturer Narrative

The device was not received for evaluation and no photo was provided; complaint not confirmed.The most likely probable cause of the event is attributed to user error due to excessive force during impacting.

• Brand Name: BROACH, PEGGED GLENOID
• Type of Device: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 15788171
• MDR Text Key: 307567018
• Report Number: 1220246-2022-05737
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867059443
• UDI-Public: 00888867059443
• 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,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BROACH, PEGGED GLENOID
• Device Catalogue Number: AR-9233
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1