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

Catalog Number	SXPP1A407
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An empty labeled winding former, a dispensed suture and a detached needle of product code sxpp1a407 were returned for analysis.During the visual inspection of the needle the swage and attachment area were as expected.The barrel hole of the needle was examined under 20x magnification and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.Per the sample condition, the assignable cause is a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.
Event or Problem Description
It was reported that the patient underwent laminectomy on (b)(6) 2019 and suture was used.The suture separated from the needle when removed from the sterile packet.A second like suture packet was opened to complete the procedure.There were no adverse patient consequences reported.Upon review of returned device, the suture was examined and the insertion did not meet the requirement.

• Brand Name: SFX SYM PDS+ VIO 18IN 0 S/A CT-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8356090
• Report Number: 2210968-2019-78972
• Device Sequence Number: 13983385
• Product Code: NEW
• UDI-Device Identifier: 10705031227644
• UDI-Public: 10705031227644
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K113004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: SXPP1A407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/20/2019
• Patient Sequence Number: 1