MAUDE Adverse Event Report: TRIMED INC. RIPCORD SYNDESMOSIS BUTTON KIT

Model Number	STA001K
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Damage to Ligament(s) (1952)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Jim fassett was notified on 02dec2022 that the pull suture in sta001k separated from the medial button during surgery.It was reported that the medial button was through the fibula bone tunnel, but not yet in the tibial bone tunnel allowing the surgeon to retrieve the device enough to apply an off-the-shelf passing suture / needle that was rethreaded through the pull suture hole in the leading edge of the button.The sales rep reported that this did not cause a delay in surgery nor did it cause the patient additional harm.There are no pictures available and the device is not available for return.

• Brand Name: RIPCORD SYNDESMOSIS BUTTON KIT
• Common Device Name: RIPCORD SYNDESMOSIS BUTTON KIT
• Manufacturer (Section D): TRIMED INC.; 27533 ave hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED, INC.; 27533 ave hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355 ; 6612557406
• MDR Report Key: 15993140
• Report Number: 2031009-2022-00004
• Device Sequence Number: 17664585
• Product Code: HTN
• UDI-Device Identifier: 00842188123849
• UDI-Public: 00842188123849
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K220650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 12/15/2022

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: 12/01/2024
• Device Model Number: STA001K
• Device Catalogue Number: STA001K
• Device Lot Number: 85305-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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