MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8710
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pgh481 batch number, and no non-conformances were identified.It was received for analysis two opened boxes with seven and ten unopened samples of product.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.Additional information was requested, and the following was obtained: did all seven sutures break during actual use on patient?- yes.If no, please indicate how many broke during actual use on patient and how many broke before use on patient? how long was the surgery prolonged? - unknown.Were there any unexpected outcomes or complications as a result of the prolonged surgery time? - no.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain - no.Reported events regarding suture breakage seven times in a row was submitted via seven medwatches 2210968-2020-02537, 2210968-2020-02538, 2210968-2020-02539, 2210968-2020-02540, 2210968-2020-02541, and 2210968-2020-02543.
Event or Problem Description
It was reported that the patient underwent a pediatric thoracic procedure on (b)(6) 2020 and the suture was used.During the surgery, the suture broke.The procedure was delayed by an undetermined amount of time.Another like suture was used to complete the procedure with no patient consequences.

• Brand Name: PROLENE SUTURE 30"(75CM) 5-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9916246
• Report Number: 2210968-2020-02542
• Device Sequence Number: 19437076
• Product Code: GAW
• UDI-Device Identifier: 10705031045842
• UDI-Public: 10705031045842
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/06/2020

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: M8710
• Device Catalogue Number: M8710
• Device Lot Number: PGH481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1