MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT FOR 2.9MM PUSHLOCK; MANUAL INSTR, GENERAL SURGICAL

Model Number	DISPOSABLE KIT FOR 2.9MM PUSHLOCK
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
On (b)(6) 2023, it was reported by an arthrex employee via email that an ar-1923ds disposable kit contained an incorrect component.No additional information was provided.Additional information is requested.Additional information provided by the sales representative: the device was used during a shoulder labral repair.The case was completed by using a conmed anchor drill with no patient harm.Device will be returned.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed based on the customer-provided picture which displays a device not listed in the bom of the ar-1923ds disposable kit for 2.9 mm pushlock.This is an internal manufacturing process issue addressed in (b)(4).Refer to record cross reference.

• Brand Name: DISPOSABLE KIT FOR 2.9MM PUSHLOCK
• Common Device Name: 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: 18055583
• Report Number: 1220246-2023-08519
• Device Sequence Number: 12280625
• Product Code: MDM
• UDI-Device Identifier: 00888867023079
• UDI-Public: 00888867023079
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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
• Operator of Device: Health Professional
• Device Model Number: DISPOSABLE KIT FOR 2.9MM PUSHLOCK
• Device Catalogue Number: AR-1923DS
• Device Lot Number: 15131035
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown