MAUDE Adverse Event Report: ARTHREX, INC. DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS; NON-DEGRADABLE FIXATN FASTENER

Model Number	DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 11/29/2023, it was reported by a sales representative via email that (2) ar-8990st-2 fibertak dx did not have two sutures; instead, they only had one.This was discovered upon opening the package during a procedure on (b)(6) 2023.Additional information received on 12/8/2023: this was discovered during a triceps repair procedure and was completed with the second ar-8990st-2 fibertak dx anchor that was faulty.The case was delayed ten minutes, and anesthesia was administered for the added time.The patient suffered no negative effects on or after the procedure.
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.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.However, an investigation was conducted with the returned sealed device.The complaint allegation is confirmed.One sealed packaged ar-8990st-2 batch 15147931 was received for investigation.The returned device was inspected, and it was noted that the device was incorrectly assembled.Refer to ncr-24255.Internal manufacturing assembly issue is the cause of the reported failure.

• Brand Name: DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 18408943
• Report Number: 1220246-2023-09687
• Device Sequence Number: 8660363
• Product Code: MBI
• UDI-Device Identifier: 00888867377370
• UDI-Public: 00888867377370
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172612
• 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,Followup
• Report Date (Section B): 08/29/2024

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: DBL LD DX FBR TK W/BLU, 0.9MM ST NDLS
• Device Catalogue Number: AR-8990ST-2
• Device Lot Number: 15147931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2023
• 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