MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC NEEDLE; BLUE POLYPROPYLENE MONOFILAMENT SHUTTLE NEEDLE

Model Number 3910-900-118

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

According the reporter, "the loop on free needle (3910-900-118) came out of the needle while suturing tape from iconix2tt anchor (3910-500-322) during hamstring repair procedure.".

Manufacturer Narrative

The device was discarded by the user and was not returned.Production records were reviewed.There were no nonconformities noted with the lot during production.All finished goods testing requirements were met prior to release.Five retained samples from the same lot were used to perform a needle detachment test.The retained samples used for the needle detachment test met requirements.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: NEEDLE
• Type of Device: BLUE POLYPROPYLENE MONOFILAMENT SHUTTLE NEEDLE
• 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: 18813297
• MDR Text Key: 336618740
• Report Number: 3006981798-2024-00010
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2024

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
• Device Operator: Health Professional
• Device Model Number: 3910-900-118
• Device Lot Number: 23062302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1