MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 0 S/A CTXB; SUTURE, SURGICAL, ABSORBABLE

Model Number	SXPP1A302
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.
Event or Problem Description
It was reported that the patient underwent an unknown orthopedic procedure on unknown date and barbed suture was used.When pulling the suture during continuous suturing, the suture was detached from the needle easily.It was not a control release needle.Further details are not provided.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device mez072 batch number, and no non-conformances were identified.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 S/A CTXB
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9601691
• Report Number: 2210968-2020-00463
• Device Sequence Number: 584890
• Product Code: NEW
• UDI-Device Identifier: 10705031227651
• UDI-Public: 10705031227651
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/25/2019

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: 04/30/2020
• Device Model Number: SXPP1A302
• Device Catalogue Number: SXPP1A302
• Device Lot Number: MEZ072
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/25/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 01/27/2020
• Patient Sequence Number: 1