MAUDE Adverse Event Report: ARTHREX, INC. RETROCONSTRUCTION CONSTANT FEMORAL GUIDE; DRILL BIT

Model Number	RETROCONSTRUCTION CONSTANT FEMORAL GUIDE
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a shoulder prothesis surgery the 3mm drill was passed through the drill sleeve and the devices then cold-welded.This resulted in abrasion.There was no harm for patient, operator or third party.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.***update (b)(6) 30-aug-2024: the abrasion did not enter the patient.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-1778r-30 serial/batch number (b)(6) was received for evaluation.Functional testing was not performed because the device arrived with other components stuck inside.Visual inspection revealed scratches and lines around the shaft outside diameter, an indication of abrasions, and the device being in contact with another instrument during use.The most likely cause of the reported failure is misuse due to user error.

• Brand Name: RETROCONSTRUCTION CONSTANT FEMORAL GUIDE
• Common Device Name: DRILL BIT
• 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: 20169364
• Report Number: 1220246-2024-07452
• Device Sequence Number: 7113397
• Product Code: HTW
• UDI-Device Identifier: 00888867021303
• UDI-Public: 00888867021303
• 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,Followup
• Report Date (Section B): 01/09/2025

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: RETROCONSTRUCTION CONSTANT FEMORAL GUIDE
• Device Catalogue Number: AR-1778R-30
• Device Lot Number: 1489154906
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2016
• 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