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	12/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/11/2023, it was reported by an arthrex subsidiary employee via email that an ar-1927bcf-45-1 bio composite corkscrew anchor broke during insertion.The case was completed using another ar-1927bcf-45-1 bio composite corkscrew from the same lot number.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 information received on 12/18/2023: the patient suffered no negative effects on or after the procedure.
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.
Additional Manufacturer Narrative
Complaint is confirmed.Visual inspection identified that the implant 4.5mm bio-corkscrew had broken from the middle to the distal end of the tip.No problems were noted with the sutures and driver.Functional testing was not performed due to the damage to the device.Per dfu-0087-13 rev 0 -per dfu-0087-13 rev 0- section g- precautions: 2.Surgeons are advised to review the product-specific surgical technique prior to performing any surgery.Arthrex provides detailed surgical techniques in print, video, and electronic formats.The arthrex website also provides detailed surgical technique information and demonstrations.Or, contact your arthrex representative for an onsite demonstration.3.Make sure to use the recommended drill bit or punch to create the bone socket.The most likely cause can be attributed to improper bone preparation 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: emily shafer ; 8009337001
• MDR Report Key: 18456561
• Report Number: 1220246-2024-00162
• Device Sequence Number: 3114740
• 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): 08/23/2024

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: 15041238
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2023
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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