MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI 18IN 3-0 SA PS-1 PRM; SUTURE, SURGICAL, ABSORBABLE

Model Number	SXPP1A100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent a spinal fusion procedure on (b)(6) 2020 and the barbed suture was used.After the cross stitch was placed on the subcutis and a surgeon was fixing the tab and putting about 3 stitches, the barbed suture broke.The surgeon opined about possible cause of the issue that while he was placing the cross stitch, the needle might have touched the portion of the suture which had already been put on/under the tissue, causing damage on the suture.The surgery time was extended 30 minutes.There were no patient consequences reported.No further information is available.

• Brand Name: SFX SYM PDS+ UNI 18IN 3-0 SA PS-1 PRM
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9936512
• Report Number: 2210968-2020-02746
• Device Sequence Number: 755242
• Product Code: NEW
• UDI-Device Identifier: 10705031227736
• UDI-Public: 10705031227736
• 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
• Report Date (Section B): 03/11/2020

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: 06/30/2021
• Device Model Number: SXPP1A100
• Device Catalogue Number: SXPP1A100
• Device Lot Number: PHZ518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1