MAUDE Adverse Event Report: ARTHREX, INC. DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, SS; WASHER, BOLT, NUT

Model Number	DISTAL CLAVICLE PLATE, 8 HOLE, LEFT, SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
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.Upon visual inspection it was noted that the device was cracked through the edge in h15 between the arthrex marking and the batch number.The thickness was measured and found to meet the specification listed in drawing (b)(4).The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.
Event or Problem Description
It was reported that during a clavicle fracture surgery while bending the plate it cracked.Nothing broke off from the device.According to the surgeon there was no harm for patient, operator or third party reported.It was not necessary to switch the surgical technique or do a second surgery.16-mar-2022 update dw further information were provided that the surgery was finished successfully with a new device with the same part number.

• Brand Name: DISTAL CLAVICLE PLATE, 8 HOLE, 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: 19567137
• Report Number: 1220246-2024-06108
• Device Sequence Number: 20571593
• Product Code: HRS
• UDI-Device Identifier: 00888867027527
• UDI-Public: 00888867027527
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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, 8 HOLE, LEFT, SS
• Device Catalogue Number: AR-2657DL
• Device Lot Number: 12738477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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