MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 1 S/A CTX; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A400

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.Attempts to obtain the device have been made.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent a myomectomy on (b)(6) 2019 and suture was used.The suture broke during use.Changed to another suture to complete the surgery.No additional information could be provided.No reported patient consequences.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 01/28/2020.Additional information: a3, d10,h6.Additional h3 device evaluation summary: one open sample of product code sxpp1a400, lot pcz679 was returned for analysis.During the visual inspection of the opened sample, the swage and attachment area were noted to be as expected.However, marks on the body needle and the end of the suture piece cut by the use of a surgical instrument could be observed.Addition, some barbs were found damaged and body fluids were found along of the strand.The product code sxpp1a400 contains an absorbable suture and as the sample was received open, the time of exposure that has the suture in the environment could not be determined and no additional test could be performed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 1 S/A CTX
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9536177
• MDR Text Key: 193693196
• Report Number: 2210968-2019-91419
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219366
• UDI-Public: 10705031219366
• Combination Product (y/n): N
• PMA/PMN Number: K113004
• 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: 12/09/2019

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 Expiration Date: 02/28/2021
• Device Model Number: SXPP1A400
• Device Catalogue Number: SXPP1A400
• Device Lot Number: PCZ679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/28/2020
• Patient Sequence Number: 1