MAUDE Adverse Event Report: ARTHREX, INC. CLAVICLE PLATING SYSTEM INSTRUMENT CASE; MANUAL INSTR, GENERAL SURGICAL

Model Number	CLAVICLE PLATING SYSTEM INSTRUMENT CASE
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a clavicula surgery it was found that the blue rubber coating from the tray was porous and was stuck on the clavicula plate.The issue was identified when the surgeon implanted the plate.The surgeon removed the plate once more and washed the particles off.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.
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.The visual evaluation of both devices confirmed the reported event.The evaluation of the first instrument case revealed that the blue rubber coating for the plates ar-2657dr and ar-2657dl are damaged (see evaluation pictures 4 ¿ 8).The evaluation of the second instrument case revealed that the blue rubber coating for the plates ar-2657dr, ar-2657dl and ar-2656dl are damaged (see evaluation pictures 9 ¿ 16).Further the labeling in both trays are faded (see evaluation picture 4, 6, 9 + 12).The most likely cause for the reported failure is wear and tear.

• Brand Name: CLAVICLE PLATING SYSTEM INSTRUMENT CASE
• 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: jared engle ; 8009337001
• MDR Report Key: 19471916
• Report Number: 1220246-2024-04985
• Device Sequence Number: 3554512
• Product Code: LXH
• UDI-Device Identifier: 00888867027374
• UDI-Public: 00888867027374
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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): 06/05/2024

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: CLAVICLE PLATING SYSTEM INSTRUMENT CASE
• Device Catalogue Number: AR-2650C
• Device Lot Number: 10752131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown