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

Model Number	DISPOSABLES KIT, FOR DX FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
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.The contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation.Based on the device damage that was reported, the most likely cause for the reported failure can be attributed to misuse.As no further investigation was able to be performed no change in harm was identified.
Event or Problem Description
On 10/1/2021, it was reported by a sales representative via email that (2) ar-8990st fibertak suture anchors would not deploy and an ar-8990ds drill guide and guide wire kit was damaged.Surgeon has to use larger anchors to complete case.

• Brand Name: DISPOSABLES KIT, FOR DX FIBERTAK
• 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: 19490331
• Report Number: 1220246-2024-05172
• Device Sequence Number: 17933373
• Product Code: HWE
• UDI-Device Identifier: 00888867264984
• UDI-Public: 00888867264984
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/07/2024

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: 04/30/2026
• Device Model Number: DISPOSABLES KIT, FOR DX FIBERTAK
• Device Catalogue Number: AR-8990DS
• Device Lot Number: 13262363
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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