MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8698G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent a skin cancer excision on (b)(6) 2019 and suture was used for closure.Towards the end of the procedure, the suture material pulled out from the needle.Another like device as used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: an empty opened box, a needle and suture piece of product code 8698, lot mjp966 were returned for analysis.During visual inspection of the sample, the swage and attachment area were noted to be as expected.The suture piece was examined along of the strand, a correct insertion mark was observed and the other extreme was cut appears to be by use of surgical instrument.In addition, the force used to detach needle from the suture could not be determined.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample, it could not be determined what may have caused the reported incident.

• Brand Name: PROLENE SUTURE 18"(45CM) 5-0 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: 8587888
• Report Number: 2210968-2019-81134
• Device Sequence Number: 1586983
• Product Code: GAW
• UDI-Device Identifier: 10705031019232
• UDI-Public: 10705031019232
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 8698G
• Device Lot Number: MJP966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 05/23/2019
• Patient Sequence Number: 1