MAUDE Adverse Event Report: B/ BRAUN SURGICAL SA OPTILENE 6/0 (0,7) 45CM DS16 (M) RCP; OTHER SUTURE

Model Number C3090211

Device Problems Break (1069); Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, (b)(4) materials, process methods or other technological characteristics are registered within the u.S.K0133890.When additional information becomes available a follow up report will be submitted.

Event Description

It was reported the sutures broke at the knot.The reporter (dentist) indicated that the suture broke at the knot a few days after surgery.This event occurred with three dental patients.Additional information is not available.This report is for the third patient.

Manufacturer Narrative

Manufacturing evaluation - analysis and results: there are no previous complaints of the same code-batch.There are (b)(4) units in our stock.We have received three closed samples to analyze the three cases.(reported separately).We have tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep).Additionally, needle attachment strength test has been conducted on the closed samples received in order to discard a faulty needle attachment during manufacturing process that could cause splitting/breakage in the thread.The needle attachment strength results fulfil the requirements of the european pharmacopoeia (ep).We have not found splitting on thread surface on the closed samples received before and after performing tests.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Furthermore, we have conducted a review of the complaint history record and there are no other complaints received regarding thread breakage of the several products manufactured with the same thread raw material batch as the complained product.As indicated in the instructions for use (ifu) of the product, when working with optilene suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders.Final conclusion: although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.

• Brand Name: OPTILENE 6/0 (0,7) 45CM DS16 (M) RCP
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B/ BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 8811894
• MDR Text Key: 151737088
• Report Number: 3003639970-2019-00548
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/17/2024
• Device Model Number: C3090211
• Device Catalogue Number: C3090211
• Device Lot Number: 119034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Date Manufacturer Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1