MAUDE Adverse Event Report: ARTHREX, INC. AVL ANGLED REAMER SLEEVE ASSEMBLY, 15; ORTHOPEDIC MANUAL SURG INSTR

Model Number AVL ANGLED REAMER SLEEVE ASSEMBLY, 15

Device Problem Material Twisted/Bent (2981)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, it was reported by a sales representative via (b)(4) that an ar-9297-15 / avl angled reamer sleeve assembly, 15 / batch: 052043 kept binding up and bent.This was discovered during an unspecified procedure, with no reported adverse effects on the patient.

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.

Event Description

Additional information received on 1/25/2024: the issue with the instruments was discovered during inspection prior to the case starting.Back up sets were used to complete the case.

Manufacturer Narrative

Additional info: b5.Arthrex previously submitted this event as a reportable malfunction out of an abundance of caution.Upon further review and evaluation of associated risk documentation, it has been determined that this event does not meet the criteria of a reportable event under 21 cfr 803.Correction: h1: malfunction to n/a.

• Brand Name: AVL ANGLED REAMER SLEEVE ASSEMBLY, 15
• Type of Device: ORTHOPEDIC MANUAL SURG INSTR
• 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: 18158613
• MDR Text Key: 328362475
• Report Number: 1220246-2023-08775
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867350038
• UDI-Public: 00888867350038
• 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: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AVL ANGLED REAMER SLEEVE ASSEMBLY, 15
• Device Catalogue Number: AR-9297-15
• Device Lot Number: 052043
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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