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)
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: did the needle pull off from the suture thread? or did the suture broke? or did the needle break? the needle pulled off from the suture thread.Any adverse patient consequences? if yes, what medical/surgical intervention was provided to manage them.Is the product available for evaluation? no adverse patient consequences.A new suture was opened and used to complete the repair.If yes, please provide name, mailing address and telephone number of the person to whom a shipper kit can be sent to aid in return of the product? the original suture and needle that broke during the repair was disposed after the surgery.
Event or Problem Description
It was reported that the patient underwent a mohs procedure on an unknown date in 2019 and suture was used.The needle broke off from the suture during use.Another like device was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• 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: 8541328
• Report Number: 2210968-2019-80625
• Device Sequence Number: 312092
• Product Code: GAW
• UDI-Device Identifier: 10705031019232
• UDI-Public: 10705031019232
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2019

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: 08/31/2023
• Device Catalogue Number: 8698G
• Device Lot Number: MKH361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/06/2019
• Patient Sequence Number: 1