MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. SUPRAMID BLACK 4/0 (1.5) 45CM DS19; OTHER SUTURE

Model Number C0712205

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

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 this code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in stock in b.Braun surgical's warehouse.We have received one open and used sample with the thread broken.However, without any closed sample we cannot carry out an analysis in order to take a decision.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.Remarks: when working with supramid suture materials great care should be taken to ensure that the use of surgical instruments, such as tweezers and needle holders do not damage the material by being pinched or kinked.Final conclusion: in spite of receiving a defective sample, without closed samples a suitable analysis cannot be performed.Nevertheless, we take note of this incidence and if any closed sample is received in the future, we will re-open the case and analyze it.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 implantation and augmentation (dental) 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.

• Brand Name: SUPRAMID BLACK 4/0 (1.5) 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: 10337360
• MDR Text Key: 201033399
• Report Number: 3003639970-2020-00277
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0712205
• Device Catalogue Number: C0712205
• Device Lot Number: 618505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: No
• 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: 65 YR
• Patient Weight: 70