MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP306H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional 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.The following information was requested but unavailable: initial procedure date procedure name: did patient return with symptoms? if yes, explain with onset date was mrt scan performed to locate missing needle piece(s)? if scanning is completed, were the needle piece(s) located? if yes, please provide location and size of needle piece(s) retained in patient.Are there any plans to remove the needle piece(s)? if yes, please indicate date is there any adverse patient outcome? has there been any medical or surgical intervention performed? surgeon's opinion if needle pieces are retained in patient.Was any defect/non-conformance noted with the device before use/ during suturing/during post-op examination or possible re-surgery? lot number.
Event or Problem Description
It was reported that the patient underwent a fascia closure in 2018 and suture was used.During the procedure, the needle broke.Parts might have fallen into the situs.No parts were found during radiological examination and ct scan.The patient is due for mrt scan.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: VCL+ VIO 27IN 2-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9180905
• Report Number: 2210968-2019-88577
• Device Sequence Number: 2615073
• Product Code: GAM
• UDI-Device Identifier: 10705031052154
• UDI-Public: 10705031052154
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/17/2019

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: VCP306H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 10/11/2019
• Patient Sequence Number: 1