MAUDE Adverse Event Report: RIVERPOINT MEDICAL ORTHOBUTTON CL; NON-ABSORBABLE FIXATION DEVICE

Model Number	RP-OBCL-20-TI
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record was performed and no issues were noted with the lot prior to release.As part of the investigation into this incident, user device damage was noted.The instructions for use for the device states "in handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders." if additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.
Event or Problem Description
According to the reporter, "the loop was broken when surgeon was trying to pull the graft through the tunnel." the event happened during an acl reconstruction surgery.

• Brand Name: ORTHOBUTTON CL
• Common Device Name: NON-ABSORBABLE FIXATION DEVICE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave; portland, or
• MDR Report Key: 10449446
• Report Number: 3006981798-2020-00006
• Device Sequence Number: 3960591
• Product Code: MBI
• UDI-Device Identifier: 00812444026269
• UDI-Public: 00812444026269
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/25/2020

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: No Information
• Device Expiration Date: 04/30/2024
• Device Model Number: RP-OBCL-20-TI
• Device Lot Number: 190151521
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other