MAUDE Adverse Event Report: ARTHREX, INC. IMPLANT SYS, DX KL SL, BC,4.75 MM, CC FT; BIO SOFT TISSUE FIXATN FASTNR

Model Number IMPLANT SYS, DX KL SL, BC,4.75 MM, CC FT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

On 02/20/2024, it was reported by a sales representative via email that an ar-8981bctj-cp implant sys, dx kl sl, bc,4.75 mm, cc ft knotless mechanism pulled out of anchor along with eyelet.Anchor was defective.

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.

• Brand Name: IMPLANT SYS, DX KL SL, BC,4.75 MM, CC FT
• Type of Device: BIO SOFT TISSUE FIXATN FASTNR
• 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: 18874260
• MDR Text Key: 337332854
• Report Number: 1220246-2024-01398
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00888867320734
• UDI-Public: 00888867320734
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/11/2024

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
• Device Operator: Health Professional
• Device Model Number: IMPLANT SYS, DX KL SL, BC,4.75 MM, CC FT
• Device Catalogue Number: AR-8981BCTJ-CP
• Device Lot Number: 15050910
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1