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

Catalog Number	8455H
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Attempts have been made to retrieve the device.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.
Event or Problem Description
It was reported that a patient underwent an umbilical hernia repair procedure on (b)(6)2019 and suture was used.The suture was used to secure the mesh.The needle passed through the mesh but exited the other side with a longitudinal split in the suture for most of its length.Another device of the same batch was used to complete the procedure.No significant delay to surgery time.There were no adverse consequences for the patient reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch lmp867- 8455h and no non-conformances were identified.One empty labeled winding former and one needle-suture of product code 8455, lot lmp867 were returned for evaluation.During the visual inspection of the sample, the swage and attachment area of the needle were noted to be as expected and the suture was observed split and frayed.In addition, the end suture was cut appears to be by use of surgical instrument.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to sample condition, it could not be determined what may have caused the reported incident of: ¿the needle passed through the mesh but exited the other side with a longitudinal split in the suture for most of its length¿.

• Brand Name: PROLENE SUTURE 30"(75CM) 1 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1210 ward avenue; west chester PA 08876 0151
• MDR Report Key: 8971470
• Report Number: 2210968-2019-86667
• Device Sequence Number: 11409360
• Product Code: GAW
• UDI-Device Identifier: 10705031015869
• UDI-Public: 10705031015869
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: 10/31/2022
• Device Catalogue Number: 8455H
• Device Lot Number: LMP867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/04/2019
• Patient Sequence Number: 1