MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 18"(45CM) 1 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP753D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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 that the patient underwent an unknown orthopedic surgery on (b)(6) 2019 and suture was used.During the procedure, the needle was detached from the suture when passing the needle through the tissue.It was a control release needle.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: it was reported performance pull off - suture needle.It was received for analysis a winding former and eight detached needles of product code vcp753d.This product code is control release and contain eight strands per packet.During the visual inspection of detached needles, the swage and attachment area were noted to be as expected.The barrel holes of the needles were examined under magnification and no suture remnant was noted and marks that appears to be by use of a surgical instrument could be observed on the body needles.The sutures were not received for evaluation to determine the assignable cause.The manufacturing records couldn't be reviewed as the batch number is unknown.It could not be determined what may have caused the reported incident of: ¿during an unknown orthopedic surgery, the needle was detached from the suture when passing the needle through the tissue.It was a control release needle¿.

• Brand Name: VICRYL PLUS SUTURE 18"(45CM) 1 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8561971
• Report Number: 2210968-2019-80799
• Device Sequence Number: 1836805
• Product Code: GAM
• UDI-Device Identifier: 10705031055339
• UDI-Public: 10705031055339
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032420
• 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): 04/02/2019

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: VCP753D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 06/15/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/26/2019
• Patient Sequence Number: 1