MAUDE Adverse Event Report: SUTURES INDIA PVT., LTD. RELI; CAT GUT SUTURE

Catalog Number	GP822-BRC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the suture needle broke during a tooth extraction procedure.A piece of the needle was recovered from the tooth socket of the patient.Unsure of how many pieces broke off from the needle, an xray was used to ensure that there was no metal remaining.
Additional Manufacturer Narrative
(b)(4) was notified of the event reported and conducted an investigation.Due to the defective device not being available from the end user, the master (retain) sample at the manufacturer was tested, see manufacturer's root cause below: as a part of investigation the master sample has been tested for needle penetration and ductility, the obtained results are compliance with the regular trend.The batch manufacturing records have been cross verified for the issuance of raw material and found satisfactory.The product has been manufactured as per the written procedure and there was no abnormality reported during manufacturing process.As a further investigation the batches manufactured prior to this lot in same profile(my51563 & my60386) which were dispatched to myco medical have been evaluated for the test needle penetration and ductility, the obtained results are meeting to the requirement.Based off the manufacturer's investigation results 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 tip of the suture needle broke during a tooth extraction procedure.A piece of the needle was recovered from the tooth socket of the patient.Unsure of how many pieces broke off from the needle, an xray was used to ensure that there was no metal remaining.

• Brand Name: RELI
• Common Device Name: CAT GUT 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: 6312767
• Report Number: 1058382-2017-00001
• Device Sequence Number: 532838
• Product Code: GAL
• UDI-Device Identifier: 10386120005857
• UDI-Public: 10386120005857
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017
• Report Date (Section F): 02/08/2017

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: Dentist
• Device Expiration Date: 01/04/2021
• Device Catalogue Number: GP822-BRC
• Device Lot Number: MY60023
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/31/2017
• Device Age: 13 MO
• Event Location: Other
• Date Report to Manufacturer: 02/09/2017
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2017
• Supplement Report FDA Received Date: 02/20/2017
• 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: 02/08/2017