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

Model Number	VCP333H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.It was reported "the sutures from this lot was snap" please clarify: what tissue was being approximated or sutured when it broke? procedure date? please clarify the intra-op event: what does it mean the suture ¿snap¿? was this the suture breakage, fraying or pull off (detached from the needle)? was the suture ¿snap¿ occurred pre-op, during suture dispensing or during use on the patient? how was this surgery completed? was this surgery completed with another/new suture product? were there any patient consequences due to the intra-op suture ¿snap¿? what is the return status of the suture ¿snap¿ during surgery? 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 that a patient underwent a spinal procedure on (b)(6) 2020; and suture was used.During the procedure, the suture snapped.Another like device was used to complete the procedure with an unspecified delay.There were no adverse patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 11/26/2020.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Investigation summary : it was reported that the sutures from this lot was snap.Two pictures were received for evaluation.Upon to visual inspection of the pictures a box and a labeled winding former with a undispensed needle-suture combination of the product code vcp333, lot # pg2105 could be observed.No samples with sutures snap were observed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as on what caused that the sutures from this lot was snap since device was not returned for analysis.It should be noted that as part of our quality process, device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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: VCL+ VIO 27IN 2-0 S/A CT-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10771422
• Report Number: 2210968-2020-08552
• Device Sequence Number: 1926764
• Product Code: GAM
• UDI-Device Identifier: 10705031052390
• UDI-Public: 10705031052390
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K132580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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 Expiration Date: 05/31/2024
• Device Model Number: VCP333H
• Device Catalogue Number: VCP333H
• Device Lot Number: PG2105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1