MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC BROADBAND LOOP; NONABSORBABLE SURGICAL SUTURE

Model Number	CM-0323N
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded and therefore was not returned.A review of the device history record was performed and all product met requirements prior to release.Investigation is still ongoing.No cause for the event has been established at this time.This report and use of categorical definitions required by fda 3500a does not constitute an admission by riverpoint medical or its employees that riverpoint medical or its employees have caused or contributed to the event described in this report.Riverpoint medical has filed this information to comply with the medical device reporting regulation 21 cfr 803.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, "it was reported that the patient underwent a primary reverse shoulder replacement on (b)(6) 2023.Subsequently, the patient underwent a revision surgery on (b)(6) 2023 to exchange the humeral bearing, glenosphere, and taper adapter.There was a continuation of the event where there was continuous wound ooze, so all implants were removed on (b)(6) 2023.".
Additional Manufacturer Narrative
Review of sterilization records showed that all products met sterilization requirements prior to release.Retain samples were pulled and underwent third-party sterility testing.The samples tested were found to be negative for growth after 14 days incubation.A cause for the event cannot be established.This report and use of categorical definitions required by fda 3500a does not constitute an admission by riverpoint medical or its employees that riverpoint medical or its employees have caused or contributed to the event described in this report.Riverpoint medical has filed this information to comply with the medical device reporting regulation 21 cfr 803.If additional information is provided to riverpoint medical regarding this event, a supplementary 3500a form will be submitted as required by the fda.

• Brand Name: BROADBAND LOOP
• Common Device Name: NONABSORBABLE SURGICAL SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer (Section G): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232
• MDR Report Key: 17756818
• Report Number: 3006981798-2023-00055
• Device Sequence Number: 12536159
• Product Code: GAT
• UDI-Device Identifier: 00810020081237
• UDI-Public: 00810020081237
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K190817
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: CM-0323N
• Device Lot Number: 22030419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown