MAUDE Adverse Event Report: RIVERPOINT MEDICAL LLC VELOSORB FAST; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	SV-9915
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during open septorhinoplasty, the needle was broken at the last step of wound closure.No needle part was remained in the patient's body.A new suture was used to complete the closure.There was no patient injury.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VELOSORB FAST
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): RIVERPOINT MEDICAL LLC; 825 ne 25th ave; portland OR 97232
• MDR Report Key: 8428357
• Report Number: 1219930-2019-01577
• Device Sequence Number: 1288683
• Product Code: GAM
• UDI-Device Identifier: 10884521153288
• UDI-Public: 10884521153288
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K120556
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 01/31/2021
• Device Model Number: SV-9915
• Device Catalogue Number: SV-9915
• Device Lot Number: 18021923X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 03/19/2019
• Initial Report FDA Received Date: 03/18/2019
• Supplement Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1