MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 4-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8871H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: was the surgery completed successfully? yes.Name of procedure: ileocolic resection by laparotomy.What is the current condition of the patient? good state, the patient came home without complication.What was the size of the needle used? 17mm 1/2c taperpoint.Was more than half the needle retained in the patient? the whole needle remained inside the patient but it could be retrieved.Was there any additional tissue damage as a result of searching for the needle piece? no.How was the needle retrieved from the patient? the tip of the needle was visible.So the surgeon could retrieve it with a needle holder.Was there any adverse consequence associated with the patient? unk.Tissue on which used? digestive tract.
Event or Problem Description
It was reported that a patient underwent a ileocolic resection by laparotomy on (b)(6) 2020 and suture was used on the digestive tract tissue.During the procedure, at the suture of a stapling line, the strand pulled off the needle.The whole needle remained inside the patient, however, tip of the needle was visible so the surgeon could retrieve it with a needle holder.There was no tissue damage as a result of searching for the needle piece.There were no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 5/13/2020.A manufacturing record evaluation was performed for the finished device batch mdq840, 8871h56 and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/17/2020.Additional h3 investigation summary: it was received for analysis twenty-two unopened samples of product code 8871h, lot mdq840.During the visual inspection of 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 strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: PROLENE SUTURE 30"(75CM) 4-0 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: 9953619
• Report Number: 2210968-2020-02972
• Device Sequence Number: 19524328
• Product Code: GAW
• UDI-Device Identifier: 10705031021549
• UDI-Public: 10705031021549
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2020

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: 03/31/2023
• Device Model Number: 8871H
• Device Catalogue Number: 8871H
• Device Lot Number: MDQ840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 05/12/2020; 06/15/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 05/13/2020; 06/17/2020
• Patient Sequence Number: 1