MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X30IN 7-0 D/A BV175-6 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8731
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Twenty-one unopened samples of product were returned for analysis.The complaint sample was not received.During the visual inspection of thirteen unopened samples, no defects were found on the packages.The samples were opened, and 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 or suture breakage were noted.A functional test was performed using an instron and the tensile strength force was above the minimum requirement.Per the condition of the samples received, no performance - breakage suture was found and the tested samples met the finished goods requirements.Four suture breakages during this procedure were submitted via medwatches: 2210968-2020-02401, 2210968-2020-02402, 2210968-2020-02404 and 2210968-2020-02405.
Event or Problem Description
It was reported that the patient underwent a cardiac procedure on (b)(6) 2020 and the suture was used.During a surgery, the suture kept breaking.The procedure was completed using another like device with no patient consequences.

• Brand Name: PRLNE BLU 4X30IN 7-0 D/A BV175-6 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9886255
• Report Number: 2210968-2020-02404
• Device Sequence Number: 14138378
• Product Code: GAW
• UDI-Device Identifier: 10705031203631
• UDI-Public: 10705031203631
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

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: 12/31/2022
• Device Model Number: EPM8731
• Device Catalogue Number: EPM8731
• Device Lot Number: MAR8971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/26/2020
• Patient Sequence Number: 1