MAUDE Adverse Event Report: ARTHREX, INC. BTB IB TIGHTROPE W FLIPCUTTER III DRILL; NON-DEGRADABLE FIXATN FASTENER

Model Number	BTB IB TIGHTROPE W FLIPCUTTER III DRILL
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 3/15/2023, it was reported by a sales representative via email that an ar-1288btbib-fc3 btb ib tightrope with a flipcutter iii drill was missing the ar-1588btb-ib internalbrace from the kit.Instead, it contained an ar-1288rtt-fc3fibertag tightrope with flipcutter iii, lot number 14688120.This was discovered upon opening the package during an aclr procedure on (b)(6) 2023.The case was completed with another ar-1288btbib-fc3 btb ib tightrope with a flipcutter iii drill.
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 allegation is confirmed.Visual inspection identified that ar-1288btbib-fc3 rev 3 is missing component c20983-01 rev 2, from the box per bom.The component found in the box is from ar-1288rtt-fc3 rev 4, component c19805-01 rev 1.The cause of the reported failure is an internal manufacturing issue.

• Brand Name: BTB IB TIGHTROPE W FLIPCUTTER III DRILL
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 19575547
• Report Number: 1220246-2024-06292
• Device Sequence Number: 18245242
• Product Code: MBI
• UDI-Device Identifier: 00888867379961
• UDI-Public: 00888867379961
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K231857
• 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
• Report Date (Section B): 06/20/2024

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: 06/30/2026
• Device Model Number: BTB IB TIGHTROPE W FLIPCUTTER III DRILL
• Device Catalogue Number: AR-1288BTBIB-FC3
• Device Lot Number: 15003639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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