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

Catalog Number	SXPP1A408
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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 or Problem Description
It was reported a patient underwent an unknown orthopedic surgery on (b)(6) 2018 and barbed suture was used.The suture was detached from the needle when pulling the suture after first passing by continuous suturing, and the fixation tab was also broken.The lot number is unknown.Further details are not provided there were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Additional information: investigation summary = > it was reported performance pull off suture needle and performance fixation feature breakage.A dispensed suture and a detached needle 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 magnification and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.Also, the fixation tab was not present on the suture since it was cut appears to be by use of surgical instrument.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Per the sample condition, the assignable cause of the performance pull off suture needle 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.According to condition of the sample, the assignable cause of performance fixation feature breakage suggest an importer handling of the sample.

• Brand Name: SFX SYM PDS+ VIO 18IN 2-0 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: 8125574
• Report Number: 2210968-2018-77456
• Device Sequence Number: 1694185
• Product Code: NEW
• UDI-Device Identifier: 10705031219335
• UDI-Public: 10705031219335
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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: SXPP1A408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 01/07/2019
• Patient Sequence Number: 1