MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. SUPRAMID BLACK 5/0 (1) 45CM DS19; OTHER SUTURE

Model Number C0712191

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

K990090.Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.Analysis and results: there are no previous complaints of the same code-batch.We have received two different cases of this code-batch regarding the same issue and from the same customer.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock.We have received 19 closed samples to analyze both complaints.We have tested the knot pull tensile strength of all the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): 0.55 kgf in average and 0.36 kgf in minimum (ep requirements: 0.31 kgf in average and 0.10 kgf in minimum).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.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.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

Event Description

It was reported that there was an issue with supramid suture.The customer reported that the thread broke during dental surgery, suturing the mucosa.The type of surgery was opening of implant and the patient outcome is good.It is also reported that no significant prolongation of surgery, surgery was finalized with a different product.The suture technique employed was interrupted, single knots.Three knots are made but on the first or second knot the suture broke.This event occurred twice the same day.The other report is submitted under mfr report number: 3003639970-2020-00268.

• Brand Name: SUPRAMID BLACK 5/0 (1) 45CM DS19
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa, 121; rubí, 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa, 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: sílvia orús ; carretera de terrassa,121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 10331073
• MDR Text Key: 200630066
• Report Number: 3003639970-2020-00276
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0712191
• Device Catalogue Number: C0712191
• Device Lot Number: 615353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 85