MAUDE Adverse Event Report: ARTHREX, INC. IMPL DELIVERY SYS,DISTAL BICEPS, BC; BIO SOFT TISSUE FIXATN FASTNR

Model Number	IMPL DELIVERY SYS,DISTAL BICEPS, BC
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 1/27/2023 it was reported by a sales representative via phone that an ar-2260bc implant delivery system had an issue.During a distal repair procedure on (b)(6) 2023, when the surgeon was opening the kit and he was putting the biocomposite screw into the patient, it would not seat in the bone.The screw was removed in one piece; nothing broke inside the patient.Another ar-2260bc implant delivery system with an unknown lot number was opened.This time, the screw sat correctly in the patient and the case was completed successfully with no impact to the patient.The device is available for return.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.  arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint confirmed.One unpackaged ar-2260bc implant delivery system serial/batch number (b)(6) was received for investigation.Functional testing was not performed due to the damage in the head hex.Visual evaluation found that the bio screw missed the symmetry on the thread and on the hex.No preparation bone information was provided.The most likely cause for the reported failure can be attributed to wear and tear.

• Brand Name: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• 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: 19458675
• Report Number: 1220246-2024-04827
• Device Sequence Number: 6812757
• Product Code: MAI
• UDI-Device Identifier: 00888867204645
• UDI-Public: 00888867204645
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K062747
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: 09/30/2024
• Device Model Number: IMPL DELIVERY SYS,DISTAL BICEPS, BC
• Device Catalogue Number: AR-2260BC
• Device Lot Number: 15008138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2023
• Initial Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown