MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 6-0 S/A PC-1 PRM MP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8617G
Medical Device Problem Codes	Break (1069); 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.
Event or Problem Description
It was reported that a patient underwent a skin cancer excision on an unknown date and suture was used for the closure.During the procedure, the needle popped off from the suture and the suture just broke in the middle.Another like device was used to complete the procedure with no adverse patient consequences.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: PRLNE BLU 18IN 6-0 S/A PC-1 PRM MP
• 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: 8758679
• Report Number: 2210968-2019-83626
• Device Sequence Number: 1488915
• Product Code: GAW
• UDI-Device Identifier: 10705031017818
• UDI-Public: 10705031017818
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 09/30/2023
• Device Catalogue Number: 8617G
• Device Lot Number: MLQ627
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 07/15/2019
• Patient Sequence Number: 1