MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM; NON-DEGRADABLE FIXATION FASTENER

Model Number	ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
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.The complaint device was not received for evaluation.Based off the information provided, the most likely cause is continually applying torque when the implant is seated and /or not advancing.
Event or Problem Description
On 09/20/2021, it was reported by a sales representative via phone that toward the end of the case, only 3 of the 5 anchors in the ar-9400-sbk speedscap implant system, were used as two swivel locks pulled out.The remaining anchors were left in the patient as they remained whole and secure.This was discovered during a total shoulder on (b)(6) 2021.The case was completed by using arthrex 4.75 swivel locks with no patient harm.

• Brand Name: ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM
• Common Device Name: NON-DEGRADABLE FIXATION 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: 19382112
• Report Number: 1220246-2024-03734
• Device Sequence Number: 3727458
• Product Code: MBI
• UDI-Device Identifier: 00888867356733
• UDI-Public: 00888867356733
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• 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): 05/23/2024

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 Expiration Date: 12/31/2025
• Device Model Number: ECLIPSE¿ SPEEDSCAP¿ IMPLANT SYSTEM
• Device Catalogue Number: AR-9400-SBK
• Device Lot Number: 12613993
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown