MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC HS FIBER; WHITE/GREEN UHMWPE POLYBLEND BRAIDED NON-ABSORBABLE SUTURE

Model Number	HS134-MU
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, "dr.(b)(6) had a problem with the last surgery.A thread loosened and the needle fell into the humeral bone.He had to bring the fluoroscopy to the operating room to find it in the patient.".
Additional Manufacturer Narrative
The device was not returned.Production records were reviewed.There were no non conformities noted with the lot during production.All finished goods testing requirements were met prior to release including needle attachment and tensile strength.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 employeees that riverpoint medical or its employees has cause or contributed to the event described in the report.Riverpoint medical 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 fda.

• Brand Name: HS FIBER
• Common Device Name: WHITE/GREEN UHMWPE POLYBLEND BRAIDED NON-ABSORBABLE SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave.; portland, or 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: 19131514
• Report Number: 3006981798-2024-00030
• Device Sequence Number: 15176382
• Product Code: GAT
• UDI-Device Identifier: 00812444026405
• UDI-Public: 00812444026405
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: HS134-MU
• Device Lot Number: 23062112
• 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: 03/25/2024
• Initial Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2023
• 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