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

Catalog Number	8412H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: event date - (b)(6).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? no.Patient's current condition - ok.Lot number mjr636.Are actual and representative samples being returned? yes.
Event or Problem Description
It was reported that a patient underwent an umbilical hernia procedure on (b)(6) 2019 and suture was used.During the procedure, the needle broke in the patient.The fragments were removed easily without additional intervention.The procedure was completed successfully.There was no adverse patient outcome.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: an opened box with twenty-one unopened samples of product code 8412, lot mjr636 were returned for analysis.During the visual inspection of thirteen samples, no defects were found on the packages.The samples were opened and the swage and attachment area were noted to be as expected; also, the tip and body of the needles were examined under magnification and no defects, damage or needle breakage were found.Besides, the resistance test was performed and no issues or anomalies were noted.According to the samples conditions, no performance: breakage needle was found.A manufacturing record evaluation was performed for the finished device lot number mjr636, and no non-conformances were identified.

• Brand Name: PROLENE SUTURE 30"(75CM) 0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8480919
• Report Number: 2210968-2019-80004
• Device Sequence Number: 1634499
• Product Code: GAW
• UDI-Device Identifier: 10705031015265
• UDI-Public: 10705031015265
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 03/11/2019

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: No Information
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 8412H
• Device Lot Number: MJR636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/17/2019
• Patient Sequence Number: 1