MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER SLEEVE, 10°; MANUAL INSTR, GENERAL SURGICAL

Model Number ANGLED REAMER SLEEVE, 10°

Device Problem Device Damaged by Another Device (2915)

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

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

The complaint allegation was confirmed.One unpackaged ar-9597-10 serial/batch number (b)(6) was received for investigation.Functional testing with the returned ar-9676 batch 02210 and 022244 reveals the devices fit together.However, the devices do not rotate smoothly.Visual evaluation observed scratches lines around the outside diameter close to the proximal and distal ends.The most likely reason for the reported failure is the wear and tear damage incurred over repeated usage.Per dfu-0023 at revision 3.C.Validation.Repeated processing has minimal effect on these devices.End of life is normally determined by wear and damage due to the intended use.

Event Description

On (b)(6) 2023, it was reported by a sales representative via sems that an ar-9597-10 angled reamer sleeve heat welded to an ar-9676 angled reamer, along with a second ar-9676 angled reamer was damaged.This occurred during a revers total shoulder case on (b)(6) 2023, when reaming the glenoid with the mgs augment reamer, the surgeon noticed that it was not performing the way it typically does.After removing the reamer and handing it off to the back table for the tech to check it, they noticed that you could not disconnect the driver shaft and outer sleeve because they had heat welded together.They opened another mgs augment tray to complete the case, but when trying to separate the drive shaft from that 10-degree augment sleeve the driver shaft was damaged.There was no patient effect reported.

• Brand Name: ANGLED REAMER SLEEVE, 10°
• 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: 17602408
• MDR Text Key: 321724683
• Report Number: 1220246-2023-07595
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867343436
• UDI-Public: 00888867343436
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANGLED REAMER SLEEVE, 10°
• Device Catalogue Number: AR-9597-10
• Device Lot Number: 37622049
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2021
• 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