MAUDE Adverse Event Report: SUTURES INDIA PVT., LTD. RELI; CHROMIC CATGUT SUTURE

Catalog Number	GC1654-BRC
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the suture needle broke near the suture attachment end while performing a tooth extraction.The physician took an x-ray of the patient's mouth to ensure no needle fragment(s) were left behind.The x-ray confirmed no needle or fragment was left behind in the patient's mouth.It is assumed by the physician, the needle or fragment was captured by suction as it was not recovered.
Additional Manufacturer Narrative
The manufacturer, sutures india was notified of the event reported and conducted an investigation.Due to the defective device not being available from the end user, the retention samples at the manufacturer were tested, see manufacturer's root cause below: retention samples of the same batch visually inspected and analyzed for ductility (needle strength) and needle detachment (needle pull) the video footage of the same has been sent for your reference.Dhr of the particular batch reviewed for the issuance of appropriate raw material which was used to manufacture this batch.Raw material test report has been cross verified for the needle strength.Initial test report were reviewed for all other parameters and all the test results are in line with the specification and process.Based off the manufacturer's investigated root cause provided above, we are moving to close the complaint file and consider this mdr to be closed.
Event or Problem Description
It was reported that the suture needle broke near the suture attachment end while performing a tooth extraction.The physician took an x-ray of the patient's mouth to ensure no needle fragment(s) were left behind.The x-ray confirmed no needle or fragment was left behind in the patient's mouth.It is assumed by the physician the needle or fragment was captured by suction as it was not recovered.

• Brand Name: RELI
• Common Device Name: CHROMIC CATGUT SUTURE
• Manufacturer (Section D): SUTURES INDIA PVT., LTD.; 472d, 13th cross, 4th phase; peenya industrial area; bengaluru, karnataka 560 0 58; IN 560 058
• MDR Report Key: 6057753
• Report Number: 1058382-2016-00004
• Device Sequence Number: 13561576
• Product Code: GAL
• UDI-Device Identifier: 00386120005331
• UDI-Public: 00386120005331
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dental Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2017
• Report Date (Section F): 03/27/2017

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: 10/05/2020
• Device Catalogue Number: GC1654-BRC
• Device Lot Number: MY52063
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/24/2016
• Device Age: 1 MO
• Event Location: Other
• Date Report to Manufacturer: 03/27/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/26/2016
• Supplement Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/27/2017