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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 11/30/2023, it was reported by an arthrex subsidiary employee via email that the drill from an ar-3600d fibertak disposables kit did not go into the guide properly.The guide might have been bent.The case was completed using another product.This was discovered during a procedure on (b)(6) 2023.Additional information received on 12/6/2023: this was discovered during a labrum repair procedure, and it was completed using a new ar-3600d fibertak disposables kit.
Additional Manufacturer Narrative
The complaint allegation is confirmed.However, the allegation that this happened upon opening the box cannot be verified due to the lack of pictures of the device inside the sealed package.One unpackaged ar-3600d was received for investigation.Functional testing found resistance in the shaft of the straight drill guide, when inserting the fibertak spear through it.Visual inspection noted striation marks on the shaft of the drill - likely incurred from the interference with the mating instrument.The most likely cause of this condition is misuse due to excessive force/friction during use or insertion.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18409862
• Report Number: 1220246-2023-09697
• Device Sequence Number: 20954757
• Product Code: HWE
• UDI-Device Identifier: 00888867239128
• UDI-Public: 00888867239128
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/15/2024

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: 14943731
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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