MAUDE Adverse Event Report: ARTHREX, INC. DISTAL CLAVICLE PLATE, SHORT, LEFT, SS; WASHER, BOLT, NUT

Model Number	DISTAL CLAVICLE PLATE, SHORT, LEFT, SS
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/15/2022, it was reported by a sales representative via email that an ar-2656 distal clavicle plate had one of the distal screw not lock in the plate.This was discovered during a clavicle fx procedure on (b)(6) 2022.Another plate was used and case was completed without further issues.
Additional 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.One unpackaged ar-2656dl was received for investigation.Visual inspection identified thread damage to the plate holes, most likely resulting from over-engaging/over-tightening during insertion.

• Brand Name: DISTAL CLAVICLE PLATE, SHORT, LEFT, SS
• Common Device Name: WASHER, BOLT, NUT
• 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: 19257572
• Report Number: 1220246-2024-02860
• Device Sequence Number: 6519840
• Product Code: HRS
• UDI-Device Identifier: 00888867027503
• UDI-Public: 00888867027503
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: DISTAL CLAVICLE PLATE, SHORT, LEFT, SS
• Device Catalogue Number: AR-2656DL
• Device Lot Number: 5261925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown