MAUDE Adverse Event Report: B.BRAUN SURGICAL SA FLEXOCRIN 0 (3.5) 90CM DS30; OTHER SUTURE

Model Number C0862568

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

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

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: 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.K990090.If additional information is received, a follow up report will be submitted.

Event Description

It was reported that the needle/damaged/broken.The reporter indicated that during a surgical procedure as part of a tibial plateau fracture: at the first pass, the needle breaks at the crimping area while use on a meniscal suture.Patient information has not been provided.Additional information has been requested, however, not yet received.

Event Description

Clarification of event details received.Internal spinal tuberosity fracture of displaced right tibial plateau.Suturing of the meniscus.

Manufacturer Narrative

Investigation: samples received: 1 used suture.Analysis and results: there are no previous complaints of this code batch.We manufactured and distributed in the market (b)(4) of this code batch.There are no units in our stock.We have received a used suture with the needle detached.The needle received has been visually analyzed and we have noticed that there are marks of the needle holder (or other surgical instrument) in the needle attachment zone.The needle has been damaged during handling of the suture as can be seen in the attached pictures.The steel in the attachment zone is deformed and the detachment from the thread is caused.As informed in the instructions for use of the product: "grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Grasping in the point area could impair the penetration performance and cause fracture of the needle.Grasping at the butt or attachment end could cause bending or breakage".We have also tested the needle bending strength of the returned needle and the result is 21.81 n fulfilling the needle specifications: minimum of 18.9 n.Moreover, needle bending strength results of the needles tested before releasing the product were 22.04 n.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: the needle received showed a damage in the attachment area caused by a wrong handling.However, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the sample received.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.No corrective/preventive actions needed.

• Brand Name: FLEXOCRIN 0 (3.5) 90CM DS30
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9165976
• MDR Text Key: 172020222
• Report Number: 3003639970-2019-00687
• Device Sequence Number: 1
• Product Code: GAR
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0862568
• Device Catalogue Number: C0862568
• Device Lot Number: 614425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Date Manufacturer Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 74