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	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/19/2023 it was reported by a sales representative via sems that an ar-3600d disposable kit for fibertak.During a case, as the surgeon loaded the drill into the corresponding drill sleeve and begin to drill, the drill bit got bound up inside the sleeve, locking the drill into the sleeve.No patient affect.
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-3638d serial/batch number (b)(6) was received for investigation.Functional testing found that the drill guide shaft was bent.The drill got stuck inside the drill guide.Visual evaluation found the device shaft was bent.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during drilling.

• 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: 19500070
• Report Number: 1220246-2024-05442
• Device Sequence Number: 7973178
• Product Code: HWE
• UDI-Device Identifier: 00888867239128
• UDI-Public: 00888867239128
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: 02/28/2026
• Device Model Number: DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT
• Device Catalogue Number: AR-3600D
• Device Lot Number: 12873535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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