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	Crack (1135)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 12/14/2023, it was reported by an arthrex subsidiary employee via e-mail that an ar-1927bct-475 suture anchor cracked.This occurred during a case, while inserting the anchor it cracked.The case was completed using a new product.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely causes of the reported failure are improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.
Event or Problem Description
Additional information was provided on 12/19/2023 where the arthrex subsidiary employee stated that this event occurred during an arcr procedure.An ar-1927pb was used to prepare the bone socket for insertion.The patient had a hard bone quality.All fragments were removed from the patient.
Additional Manufacturer Narrative
Additional information: b5, g3, h6.

• 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: emily shafer ; 8009337001
• MDR Report Key: 18482950
• Report Number: 1220246-2024-00226
• Device Sequence Number: 19513786
• Product Code: MAI
• UDI-Device Identifier: 00888867237858
• UDI-Public: 00888867237858
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173788
• 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,Followup
• Report Date (Section B): 12/19/2024

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: 14989373
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 10/11/2024; 12/19/2023
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 10/28/2024; 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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