MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS APEX IMPACTOR/EXTRACTOR; ORTHOPEDIC MANUAL SURG INSTR

Model Number UNIVERS REVERS APEX IMPACTOR/EXTRACTOR

Device Problem Device Damaged by Another Device (2915)

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

Event Date 03/09/2021

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, no thread damage was observed.During a visual inspection what appears to be the identification numbers of another device imprinted on the surface of the device.A likely cause of the imprint is mishandling the device.

Event Description

It was reported that the threads on the ar-9511-2 are damaged.

• Brand Name: UNIVERS REVERS APEX IMPACTOR/EXTRACTOR
• 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: jared engle ; 8009337001
• MDR Report Key: 19155005
• MDR Text Key: 341393048
• Report Number: 1220246-2024-02221
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867301870
• UDI-Public: 00888867301870
• 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: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNIVERS REVERS APEX IMPACTOR/EXTRACTOR
• Device Catalogue Number: AR-9511-2
• Device Lot Number: 05190704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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