MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT; POWERED SURG ORTHOPEDIC INSTR

Model Number	DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
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 is confirmed.Upon evaluation, the drill was stuck inside the drill guide, and the flat drill male had damage.The obturator, implant, and sutures do not have any issues.Functional testing is not performed due to the damage to the devices.The most likely cause of this condition is excessive force/friction during use.
Event or Problem Description
It was reported that during a right shoulder stabilisation / laterget surgery during the initial preperation for insertion of the anchor, the drill bit was stuck in the drill guide and could not be removed.The first anchor insertion site could be prepared but no subsequent anchors could be used.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device from another manufacturer.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT
• Common Device Name: POWERED SURG ORTHOPEDIC 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: 19441987
• Report Number: 1220246-2024-04634
• Device Sequence Number: 8321916
• Product Code: HWE
• UDI-Device Identifier: 00888867239128
• UDI-Public: 00888867239128
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 05/31/2024

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: DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT
• Device Catalogue Number: AR-3600D
• Device Lot Number: 14964609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 06/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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