MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 1 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8455H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch pmh413, 8455h and no non-conformances were identified.(b)(4).Investigation summary: an empty opened box, three empties opened overwrap and eighteen unopened samples were returned to ethicon inc for evaluation.Visual inspection and functional testing were conducted on thirteen returned devices.Visual analysis of thirteen returned samples revealed that the 8455h samples were returned with no apparent damage on the packages.The samples were opened, and 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 or damaged or suture breakage were noted.A functional test was performed and the tensile strength force was above the minimum requirement.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.It should be noted that as part of our quality process, device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The device performed without any defect noted and the actual complaint sample was not returned for analysis.Additional information was requested and the following was obtained: did the issue (breakage suture) occurred in one particular procedure? yes.What was the initial procedure? colon resection.What is the event day and procedure date? (b)(6) 2021.When did the issue (breakage suture) occurred? pre-op, intra-op or post-op.Intra-op could you please confirm if it was reported the other breakage suture? if yes could you please provide pc numbers? no, i was told multiple sutures (3) broke off (like a pop-off) in a single case.Note: events reported in 2210968-2021-00970, and 2210968-2021-00971.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a colon resection on (b)(6) 2021 and suture was used.During the procedure, the suture broke right off when used.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: PROLENE SUTURE 30"(75CM) 1 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: 11266446
• Report Number: 2210968-2021-00969
• Device Sequence Number: 1167006
• Product Code: GAW
• UDI-Device Identifier: 10705031015869
• UDI-Public: 10705031015869
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

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: 10/31/2024
• Device Model Number: 8455H
• Device Catalogue Number: 8455H
• Device Lot Number: PMH413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/02/2021
• Patient Sequence Number: 1