MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER, DRIVE SHAFT; MANUAL INSTR, GENERAL SURGICAL

Model Number ANGLED REAMER, DRIVE SHAFT

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/16/2022

Event Type  malfunction  

Manufacturer Narrative

This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint not confirmed.Upon visual inspection it was noted that there were circumferential abrasions to the distal end of the device.There were also circumferential abrasions to the proximal end of the device near the shoulder and approximately 0.750 in from the shoulder.The device was not received assembled to an ar-9297-20.The device was not bent.

Event Description

On 08/16/2022, it was reported by a sales representative via sems that (2) ar-9676 angled reamers were bent when trying to ream.This occurred during a reverse total shoulder arthroplasty, the patient had hard bone, and there was no patient effect reported.Additional information provided on 08/17/2022 via sems, it was reported that (2) ar-9597-20 angled reamer sleeves spot welded to the shafts.The patient had hard bone, and it seemed to stop, and get stuck.

• Brand Name: ANGLED REAMER, DRIVE SHAFT
• 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: jared engle ; 8009337001
• MDR Report Key: 19006503
• MDR Text Key: 338952258
• Report Number: 1220246-2024-01739
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867324954
• UDI-Public: 00888867324954
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANGLED REAMER, DRIVE SHAFT
• Device Catalogue Number: AR-9676
• Device Lot Number: 022119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1