MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 3-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8832H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Investigation summary: it was reported: suture breakage.Two sealed boxes with thirty-six unopened samples and an opened box with twenty-two unopened samples of product code (b)(4), lot mph938.As total 92 unopened samples were returned for analysis.During the visual inspection of thirty-two 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 and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no suture breakage was found and the tested samples met the finished goods requirements.
Event or Problem Description
It was reported that a patient underwent a surgical procedure on an unknown date and suture was used.The surgeon was having issues with the suture breaking.It is unknown where the suture was breaking.The procedure was completed with an alternate like device with no adverse patient consequences reported.

• Brand Name: PROLENE SUTURE 30"(75CM) 3-0 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: 8496653
• Report Number: 2210968-2019-80168
• Device Sequence Number: 1254118
• Product Code: GAW
• UDI-Device Identifier: 10705031021013
• UDI-Public: 10705031021013
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/14/2019

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: 11/30/2023
• Device Catalogue Number: 8832H
• Device Lot Number: MPH938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 04/09/2019
• Patient Sequence Number: 1