MAUDE Adverse Event Report: ARTHREX, INC. BC, CORKSCREW FT, TRI-PLAY, 4.75MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	BC, CORKSCREW FT, TRI-PLAY, 4.75MM
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	12/29/2022
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
It was reported on (b)(6) 2022 by a sales representative via email that an ar-1927bcf-475 corkscrew anchor broke into pieces.Case involvement, device broke during use.Per facility: the bone socket was prepared with the 4.75 corkscrew punch/tap and the bone was tapped twice.Upon insertion, the anchor broke prior to the last 3-4 threads being fully seated.Outcome: the entire anchor was able to be retrieved from the patient in multiple pieces.The same hole was tapped with a 5.5 tap and a 5.5 corkscrew was unsuccessfully attempted to be inserted.The doctor completed the procedure by drilling and tapping in an alternative area on the bone, using 5.5 corkscrew.
Additional Manufacturer Narrative
Additional information: d9, g3, h6.Since the complaint device was not returned, a physical evaluation of the device was not performed.However, without the device being returned or any photos provided, the complaint allegation is not confirmed.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: BC, CORKSCREW FT, TRI-PLAY, 4.75MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16173455
• Report Number: 1220246-2023-06120
• Device Sequence Number: 11847485
• Product Code: MAI
• UDI-Device Identifier: 00888867238541
• UDI-Public: 00888867238541
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 06/25/2024

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 Expiration Date: 05/31/2026
• Device Model Number: BC, CORKSCREW FT, TRI-PLAY, 4.75MM
• Device Catalogue Number: AR-1927BCF-475
• Device Lot Number: 14971614
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown