MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 2-0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A403

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Lot number for the device involved in the event?.

Event Description

It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The suture broke during use on the patient intra-operatively.The surgeon sutured a small area again during the same procedure.There were no adverse patient consequences reported.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 2-0 S/A CT-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10870179
• MDR Text Key: 217432379
• Report Number: 2210968-2020-09137
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219328
• UDI-Public: 10705031219328
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1A403
• Device Catalogue Number: SXPP1A403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1