MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SPIRAL MONOCRYL+; SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID

Catalog Number	SXMP1B410
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2019
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 robotic ventral hernia repair on (b)(6) 2019 and a barbed suture was used.During the procedure, the suture broke at the sewege while the surgeon was closing the paratanium.The suture did separate completely from the needle.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: STRATAFIX SPIRAL MONOCRYL+
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYGLCOLIC ACID
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8367670
• Report Number: 2210968-2019-79037
• Device Sequence Number: 2034996
• Product Code: GAM
• UDI-Device Identifier: 10705031236448
• UDI-Public: 10705031236448
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019

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: 07/31/2020
• Device Catalogue Number: SXMP1B410
• Device Lot Number: MJJ804
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 02/25/2019
• Patient Sequence Number: 1