MAUDE Adverse Event Report: RIVERPOINT MEDICAL HI FI; SUTURE

Model Number	8536
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Foreign Body In Patient (2687)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation and the metal fragment could not be linked to the device in question.A lot number for the product was requested but not provided by the reporter.An investigation into complaint history and ncr history for the product was performed, no negative quality trends were identified associated with this product.The alleged deficiency described could not be substantiated.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 needle broke during use without the surgeon's knowledge and fragment was inadvertently left in the patient." reporter also noted that the "patient underwent surgery performed by <> to remove the metal which turned out to be a portion of a meniscus repair needle.It was successfully extracted.".

• Brand Name: HI FI
• Common Device Name: SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 11805737
• Report Number: 3006981798-2021-00004
• Device Sequence Number: 19683173
• Product Code: GAT
• UDI-Device Identifier: 20653405002045
• UDI-Public: 20653405002045
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K100006
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8536
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/11/2021
• 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: Hospitalization; Other