MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 6IN 3-0 SA PS-2 PRM; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1B103

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: what was the size of the needle used? =>19mm, ps-2.The following information was requested, but unavailable: what tissue structure is it located?.Size of the needle piece retained? are any plans in place to remove the needle piece in future?.If retained, what is the surgeon's opinion of consequences to the patient? was there any additional tissue damage as a result of searching for the needle piece within 30 minutes? what is current condition of the patient? was more than half the needle retained in the patient? no further information will be provided.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient underwent a transabdominal preperitoneal surgery on (b)(6) 2020 and the suture was used.During surgery, the needle was inserted into the patient¿s body through a port without being bent.Then, the needle was broken at the tip when suturing the peritoneum under a laparoscope.The broken piece has not been retrieved.The operation time was extended within 30 minutes.There were no adverse consequences to the patient.No further information is available.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 01/14/2020.A manufacturing record evaluation was performed for the finished device pdp606, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: SFX SPI PDS+ UNI VIO 6IN 3-0 SA PS-2 PRM
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10871849
• MDR Text Key: 217372029
• Report Number: 2210968-2020-09142
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031236233
• UDI-Public: 10705031236233
• Combination Product (y/n): N
• PMA/PMN Number: K150670
• 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: 10/28/2020

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 Expiration Date: 03/31/2024
• Device Model Number: SXPP1B103
• Device Catalogue Number: SXPP1B103
• Device Lot Number: PDP606
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1