MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPSI CRKSCRW FT 4.5X 14MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMPSI CRKSCRW FT 4.5X 14MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/11/2023, it was reported by an arthrex subsidiary employee that an ar-1927bcf-45 corkscrew ft anchor broke during insertion.The case was completed using another ar-1927pcf-45 corkscrew.This was discovered during an rcr procedure on (b)(6) 2023.All the broken fragments were removed, and the case was delayed ten minutes; however, no additional anesthesia was needed.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in d8/9, h3, h6: type of investigation, investigation findings, investigation conclusions, h10 and g1.Complaint is confirmed.Visual inspection identified that the implant 4.5mm bio-corkscrew of the 4.5 mm biocomposite-corkscrew® ft suture anchor with one #2 fiberwire® and one tigerwire® had broken.Functional testing was not performed due to the damage to the device.The most likely cause can be attributed to excessive force being used or prying/leveraging the screw during insertion.

• Brand Name: BIO-COMPSI CRKSCRW FT 4.5X 14MM
• 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: 18453082
• Report Number: 1220246-2024-00129
• Device Sequence Number: 15212240
• Product Code: MAI
• UDI-Device Identifier: 00888867282391
• UDI-Public: 00888867282391
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082810
• 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
• Report Date (Section B): 06/27/2024

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: BIO-COMPSI CRKSCRW FT 4.5X 14MM
• Device Catalogue Number: AR-1927BCF-45-1
• Device Lot Number: 15077515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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