MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC HI-FI SUTURE WITH DOUBLE ARMED MENISCAL NEEDLES; NONABSORBABLE SURGICAL SUTURE

Model Number	8536
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "during meniscus repair surgery, 8536 double arm needle was used, and seven were used for patients.Two of them were opened with plastic packaging and paper boxes opened to use the product, but they were not included.".
Additional Manufacturer Narrative
The device will not be returned and no pictures of the device issue were provided.Production records were reviewed.There were no nonconformities noted with the lot during production.All finished goods testing requirements were met prior to release.Three retained samples from the same lot were examined to verify that the product was present inside the paper boxes.All retained samples had product present and no nonconformities.There was no evidence that the device failed to meet specifications, and the report could not be substantiated.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: HI-FI SUTURE WITH DOUBLE ARMED MENISCAL NEEDLES
• 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: 17217163
• Report Number: 3006981798-2023-00038
• Device Sequence Number: 3023559
• Product Code: GAT
• UDI-Device Identifier: 00810020085891
• UDI-Public: 810020085891
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K100006
• 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
• Type of Report: Initial
• Report Date (Section B): 06/28/2023

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 Model Number: 8536
• Device Lot Number: 22080823
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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