MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC SPLIT STITCH; POLYBLEND BRAIDED STERILE NONABSORBABLE SUTURE

Model Number	VAL0220SS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.A review of device history record was performed and no issues were noted during manufacturing and all product met requirements prior to release.The report could not be substantiated and a cause for the event could not be established.
Event or Problem Description
According to the reporter, "suture shredded during the tendon transfer.".

• Brand Name: SPLIT STITCH
• Common Device Name: POLYBLEND BRAIDED STERILE NONABSORBABLE SUTURE
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• Manufacturer Contact: edwin anderson ; 825 ne 25th ave; portland, OR 97232 ; 5038178001
• MDR Report Key: 14246703
• Report Number: 3006981798-2022-00010
• Device Sequence Number: 11861748
• Product Code: GAT
• UDI-Device Identifier: 00818614020105
• UDI-Public: 00818614020105
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2022

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 Expiration Date: 10/31/2025
• Device Model Number: VAL0220SS
• Device Lot Number: 20111718
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• 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