MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 8X18IN 0 S/A CT-1 CR; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	CX21D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/13/2020.A manufacturing records evaluation was performed for batch mjp788, cx21d and no non-conformance's were identified.Investigation summary: two opened boxes with as total of twenty unopened samples of product code cx21d, lot mjp788 were received for analysis.The complaint sample was not received for analysis.During visual inspection of unopened samples, no defects were found on the packages.Samples were opened and contains eight strands; the swage and attachment area of needle-sutures were noted to be as expected.The sutures were dispensed without problems and examined along of the strand and no defects or damaged were found.A functional test was performed and the pull force results meet the customer 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 samples received, no performance needle pull off was found, and the tested samples met the finished goods requirements.Additional information was requested and the following was obtained: specific number of sutures from the 2 boxes which had needle pull off issue in this procedure.- 16 qty, every one that they tried pulled off.For each involved device, please specify when did the issue occur- upon dispensing (before use on patient) or during suturing? - in or during suturing.Did any device had suture thread broken during use? if yes, please provide quantity of devices with suture thread broken issue.- upon use, the suture popped off of the needle immediately.How was case completed? - we used a different suture with a smaller needle.Any patient consequences?what medical/surgical intervention was performed to manage them? - n/a.Note: events reported via mw 2210968-2020-02034, 2210968-2020-02035, 2210968-2020-02036, 2210968-2020-02037, 2210968-2020-02038, 2210968-2020-02039, 2210968-2020-02040, 2210968-2020-02041, 2210968-2020-02042, 2210968-2020-02045, 2210968-2020-02046, 2210968-2020-02047, 2210968-2020-02048, 2210968-2020-02049, 2210968-2020-02050, 2210968-2020-02051.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.The needle pulled off the suture right away and product could not be used.It was reported the issue occurred during suturing.There were no adverse patient consequences reported.

• Brand Name: EB EXC GRN 8X18IN 0 S/A CT-1 CR
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9831658
• Report Number: 2210968-2020-02041
• Device Sequence Number: 2929518
• Product Code: GAT
• UDI-Device Identifier: 10705031024229
• UDI-Public: 10705031024229
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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: 07/31/2023
• Device Model Number: CX21D
• Device Catalogue Number: CX21D
• Device Lot Number: MJP788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/13/2020
• Patient Sequence Number: 1