MAUDE Adverse Event Report: B. BRAUN SURGICAL, S.A. SUPRAMID BLACK 3/0 (2) 75CM DS19; OTHER SUTURE

Model Number C0714216

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported an issue with supramid suture.The client reported that during suturing of the gingival mucosa, the needle became dislodged from the thread during knotting, fortunately without consequences.There were no injuries to the patient.No more information has been provided.

Manufacturer Narrative

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.K151165.If additional information becomes available a follow up report will be submitted.

Manufacturer Narrative

Analysis and results: there are no previous complaints of the same code-batch.We manufactured and distributed in the market (b)(4) units of this code-batch.There are no units in our stock.We have not received any sample for analysis, but a picture of a detached and used needle with blood that shows that the needle has been hold with a needle holder in the attachment area.We have reviewed the batch manufacturing records of the needle and the needles tested before releasing the product into the market had conforming bending strength and ductility performances.Bending strength minimum requirement is 8,6 nxcm and the results of the involved needles batches were 9,86 nxcm, 9,56 nxcm and 10,75 nxcm.Although without any closed sample we cannot carry out an analysis in order to take a decision, taking into account the picture received, the case is considered not confirmed due to a handling error.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfils usp/ep and b.Braun surgical requirements.We have also reviewed the complaint history record, and there are no previous complaints in any of the other products manufactured with the same needle raw material batches used in this product.Please note that in the instructions for use of the product, in the precautions area it is informed: when working with suture materials great care must be taken to ensure that the use of surgical instruments, such as tweezers and needleholder, does not lead to damage by pinching and kinking.Always grasp the needle in a section 1/3 to 1/2 of the distance from the fibre attachment end to the needle point, never at the end where the fibre is attached or the needle point.Grasping the needle at the area of its point could impair the penetration performance and cause a fracture of the needle.Grasping the needle close to the fibre attachment end could cause bending or breakage.Reshaping needles should be avoided and may result in a loss of their strength and resistance towards bending and breaking.Final conclusion: taking into account that the picture received shows a product that has been damaged due to handling error, we conclude that the complaint is not confirmed by evidence of the picture received.Please note that when no samples are received our analysis is very limited.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.

• Brand Name: SUPRAMID BLACK 3/0 (2) 75CM DS19
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL, S.A.; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• Manufacturer Contact: martina laporte ; carretera de terrassa 121; rubí, barcelona 08191 ; SP 08191
• MDR Report Key: 16395148
• MDR Text Key: 309995280
• Report Number: 3003639970-2023-00053
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

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
• Device Operator: Health Professional
• Device Model Number: C0714216
• Device Catalogue Number: C0714216
• Device Lot Number: 621054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 05/19/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• 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