MAUDE Adverse Event Report: ARTHREX, INC. ANGLED REAMER SLEEVE, 20°; MANUAL INSTR, GENERAL SURGICAL

Model Number ANGLED REAMER SLEEVE, 20°

Device Problems Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, it was reported by a sales representative via sems-06061144 that an ar-9676 angled reamer was bent and would not spin freely without catching the ar-9597-10, and ar-9597-20 angled reamer sleeves.This occurred during a reverse total shoulder arthroplasty procedure on (b)(6) 2023 it would catch worse on the 20 degrees than the 10 degrees.The procedure was completed utilizing a different augmented reamer set.There was no patient effect reported.

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

Additional information: h6.Complaint is confirmed.Visual evaluation found that ar-9597-20 had nicks on the edges around the device, abrasion marks on the base of the angled reamer and inside diameter, also and scratches on the collar.Functional testing with the mating part ar-9676 reveals that the device got stuck and did not rotate freely.The device did not work as required due to the damage.The most likely cause for the reported failure can be attributed to user error of the device due to interference with the mating instrument.

• Brand Name: ANGLED REAMER SLEEVE, 20°
• 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: 18103626
• MDR Text Key: 327766250
• Report Number: 1220246-2023-08643
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867343450
• UDI-Public: 00888867343450
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANGLED REAMER SLEEVE, 20°
• Device Catalogue Number: AR-9597-20
• Device Lot Number: 37622051
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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