MAUDE Adverse Event Report: ARTHREX, INC. PIN DRIVER ATTACHMENT 1.0-2.4 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number PIN DRIVER ATTACHMENT 1.0-2.4 MM

Device Problem Defective Device (2588)

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

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported that the locking mechanism for the wires is too weak.There was no harm for patient, operator or third party reported.There was no case involvement reported.No further information received.

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

Update from 02-apr-2024.According due to the customer information the problem was notices during the reprocessing process in the aemp.

Manufacturer Narrative

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.

• Brand Name: PIN DRIVER ATTACHMENT 1.0-2.4 MM
• Type of Device: POWERED SURG ORTHOPEDIC 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: 18995122
• MDR Text Key: 338929629
• Report Number: 1220246-2024-01696
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 00888867100176
• UDI-Public: 00888867100176
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIN DRIVER ATTACHMENT 1.0-2.4 MM
• Device Catalogue Number: AR-300PD24
• Device Lot Number: 15088963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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