MAUDE Adverse Event Report: ARTHREX, INC. KL FBTK RC W/ (BLU)FT & (W/BLK)#2 MTS; ARTHROSCOPIC ACCESSORIES

Model Number	KL FBTK RC W/ (BLU)FT & (W/BLK)#2 MTS
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device has 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
It was reported that, during a right shoulder cuff repair surgery, the anchor just pulled out.There was no harm for patient, operator or third party.The surgery was finished successfully with a different device.The surgeon switched to another surgical technique.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-3653tsp serial/batch number (b)(6) was received for investigation.Functional testing was not performed as it is not applicable to this device.Visual inspection of the returned device revealed no problems with the inserter.However, the evaluation showed that the sutures in the anchor system were frayed.The most likely causes of the reported failure are improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: KL FBTK RC W/ (BLU)FT & (W/BLK)#2 MTS
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 19466937
• Report Number: 1220246-2024-04907
• Device Sequence Number: 12625602
• Product Code: MBI
• UDI-Device Identifier: 00888867370067
• UDI-Public: 00888867370067
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K232973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: KL FBTK RC W/ (BLU)FT & (W/BLK)#2 MTS
• Device Catalogue Number: AR-3653TSP
• Device Lot Number: 14984211
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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