MAUDE Adverse Event Report: ARTHREX, INC. PERC INSERT KIT FOR 2.9MM P-LCK; ORTHOPEDIC MANUAL SURG INSTR

Model Number PERC INSERT KIT FOR 2.9MM P-LCK

Device Problem Device Damaged by Another Device (2915)

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

Event Date 12/09/2021

Event Type  malfunction  

Event Description

It was reported that during a posterior stablization the nitinol wire does not run smoothly through the big needle.The surgeon reported that there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

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 confirmed.From the ar-1923pk percutaneous insertion kit, only received the guide pin, distension needle and stylet, unpackaged.Visual evaluation showed the distension needle shaft is bent.No damaged noticed to the stylet or guide pin.During device functional testing, it was noticed that the guide pin and stylet had difficulty passing through the distension needle, due to the bent needle.As the devices were found to meet specification, the most likely cause is flexion of the needle due to an external force during use.

• Brand Name: PERC INSERT KIT FOR 2.9MM P-LCK
• 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: 19215397
• MDR Text Key: 342014953
• Report Number: 1220246-2024-02640
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867096745
• UDI-Public: 00888867096745
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PERC INSERT KIT FOR 2.9MM P-LCK
• Device Catalogue Number: AR-1923PK
• Device Lot Number: 13063909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1