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	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a shoulder arthroscopy the wire and drill guide got cold welded.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The reported event was confirmed as the evaluation of the received ar-3600d with batch 15356252 revealed that an unknown drill bit was stuck inside of the drill guide.Approximately 15mm is protruding from the distal end.The drill will not spin within the drill guide, it is cold-welded (see evaluation pictures 1 - 3).The most likely causes of the reported failure are misaligned insertion, and prying/leveraging the device during 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: jared engle ; 8009337001
• MDR Report Key: 22535307
• Report Number: 1220246-2025-02943
• Device Sequence Number: 7487605
• Product Code: HWE
• UDI-Device Identifier: 00888867239128
• UDI-Public: (01)00888867239128(11)241203(17)291130(10)15356252
• 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): 09/04/2025

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: DISPOSABLES KIT, FOR FIBERTAK,STRAIGHT
• Device Catalogue Number: AR-3600D
• Device Lot Number: 15356252
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown