MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 6-0 S/A P-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J489G
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device phm595 batch number, and no non-conformances were identified.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.Note: events reported via mw # 2210968-2020-06901.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2020 and suture was used.The surgeon passed the suture through the skin and due to how rough the suture passed and not pulling through as easily as usual, the surgeon looked closer and noticed it came out frayed on the other side.The surgeon opened a suture from a box with different lot and it worked fine.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/27/2020 additional information: d10, h6 additional h3 investigation summary: it was received for analysis a winding former and a needle-suture piece of product code j489g, lot phm595.During visual inspection of the sample, the swage and attachment area were noted to be as expected and the suture it was frayed, curly and the end cut appears to be by use of surgical instrument could be observed.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.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.It was received for analysis three opened samples of product code j489g, lot phm595.During the visual inspection of the samples, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects, damaged, fraying or kinked suture 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.The device performed without any difficulties noted.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 CT BRD UD 18IN 6-0 S/A P-1 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10535068
• Report Number: 2210968-2020-06902
• Device Sequence Number: 17111900
• Product Code: GAM
• UDI-Device Identifier: 10705031040427
• UDI-Public: 10705031040427
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022269
• 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): 08/19/2020

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: 06/30/2024
• Device Model Number: J489G
• Device Catalogue Number: J489G
• Device Lot Number: PHM595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 10/27/2020
• Patient Sequence Number: 1