MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 1 S/A CPX; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J569H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.Additional information was requested and the following was obtained: was surgery delayed due to the reported event? --> yes.If yes, number of minutes: --> 2.Action taken when event occurred? --> completed with another suture.Was procedure successfully completed? --> yes.Were fragments generated? --> no.If yes, were they removed easily without additional intervention? --> unknown.If no, explain --> no fragments.Patient status/ outcome / consequences --> no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> no.
Event or Problem Description
It was reported that a patient underwent a tka procedure on (b)(6) 2019 and suture was used.The suture broke away from the swage of the needle during closure of the knee.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Additional information: concomitant medical products, evaluation codes.Additional investigation summary: unopened samples of product code j569h, lot # pgm421 were returned for analysis.During the visual inspection of unopened samples, no defects were found on the packages.The samples were opened and 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, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the sample received, no pull off suture needle was found, and the tested sample met the finished goods requirements.

• Brand Name: VCL CT BRD UD 27IN 1 S/A CPX
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9286655
• Report Number: 2210968-2019-89622
• Device Sequence Number: 10795373
• Product Code: GAM
• UDI-Device Identifier: 10705031041295
• UDI-Public: 10705031041295
• 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): 10/10/2019

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 Expiration Date: 05/31/2024
• Device Catalogue Number: J569H
• Device Lot Number: PGM421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/02/2019
• Patient Sequence Number: 1