MAUDE Adverse Event Report: ARTHREX, INC. CORING REAMER, 12MM WITH COLLARED PIN; ORTHOPEDIC MANUAL SURG INSTR

Model Number	CORING REAMER, 12MM WITH COLLARED PIN
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tunnel filling with iliac crest cancellous bone with the help of the ordered hollow burrs (12mm) something went wrong during the second use of the device.The provided pictures show that the depth graduation shaft of the device is cracked and bent at the tip.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with he 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.Complaint is confirmed.One unpackaged ar-1227s serial/batch number (b)(6) was received for investigation.Component c2318-16-cannulated coring reamer 12mm was received for investigation - no collared pin, 12 mm was received with the device.Visual inspection identified that the cannulate coring reamer shaft at the distal end close to the teeth of the reamer is cracked and open.More in-depth visual evaluation observed heavy scratches lines in the inside diameter at the distal end close to the device's teeth and along the device shaft.The most likely cause for the reported failure can be attributed to user-applied excessive mechanical forces upon insertion/use.However, the most probable cause is applying excessive mechanical forces upon insertion/use.

• Brand Name: CORING REAMER, 12MM WITH COLLARED PIN
• Common Device Name: ORTHOPEDIC MANUAL SURG 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: 19489682
• Report Number: 1220246-2024-05153
• Device Sequence Number: 15245002
• Product Code: LXH
• UDI-Device Identifier: 00888867005709
• UDI-Public: 00888867005709
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/06/2024

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 Expiration Date: 08/31/2025
• Device Model Number: CORING REAMER, 12MM WITH COLLARED PIN
• Device Catalogue Number: AR-1227S
• Device Lot Number: 11751313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• 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