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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
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 ft.This was discovered during an rcr procedure on (b)(6) 2023.All the broken fragments were removed, and the case was delayed fifteen minutes; however, no additional anesthesia was needed.The patient suffered no negative effects on or after the procedure.
Additional Manufacturer Narrative
Investigation summary: complaint is confirmed.Visual inspection identified that the implant 4.5 mm bio-corkscrew was not returned for investigation and the blue suture of the 4.5 mm biocomposite-corkscrew® ft suture anchor with one #2 fiberwire® and one tigerwire.The investigation was performed per picture evaluation that confirms the bio-corkscrew was broken/detached from the device.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to excessive impaction during anchor insertion and/or prying/leveraging during use.

• 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: 18452544
• Report Number: 1220246-2024-00125
• Device Sequence Number: 15226956
• 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 Expiration Date: 04/30/2026
• Device Model Number: BIO-COMPSI CRKSCRW FT 4.5X 14MM
• Device Catalogue Number: AR-1927BCF-45-1
• Device Lot Number: 14962487
• 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: 05/19/2022
• 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