MAUDE Adverse Event Report: ARTHREX, INC. CORKSCREW FT, BC, SUTURETAPE, 4.75M; BIO SOFT TISSUE FIXATN FASTNR

Model Number	CORKSCREW FT, BC, SUTURETAPE, 4.75M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation and/or prying/leveraging during insertion.
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that (3) ar-1927bct-475 biocomposite corkscrew ft anchors failed.One failed on the first thread, the second failed when the driver snapped, and the third cracked about halfway in.Surgeon elected to use bone tunnels in lieu of suture anchors to complete the case.Additional information received on 11/14/2022: this was discovered during a quad tendon repair on (b)(6) 2022.Ar-1927bct-475 biocomposite corkscrew ft anchor, from lot number 10494037, broke when screwing it in on the first torque.Another ar-1927bct-475 biocomposite corkscrew ft inserter broke while surgeon was attempting to implant the screw, the torque was too much on the inserter.The anchor itself did not break but it was removed from the patient.The inserter did not break inside the patient.A third ar-1927bct-475 biocomposite corkscrew ft anchor broke and all fragments were retrieved.

• Brand Name: CORKSCREW FT, BC, SUTURETAPE, 4.75M
• Common Device Name: 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: 19072486
• Report Number: 1220246-2024-01917
• Device Sequence Number: 20539454
• Product Code: MAI
• UDI-Device Identifier: 00888867237858
• UDI-Public: 00888867237858
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K173788
• 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
• Report Date (Section B): 04/09/2024

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: CORKSCREW FT, BC, SUTURETAPE, 4.75M
• Device Catalogue Number: AR-1927BCT-475
• Device Lot Number: 10494037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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