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)
Date of Event	04/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent to the fda.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 total knee arthroplasty on (b)(6) 2020 and a barbed suture was used.During the procedure, the suture was detached from the needle during continuous suturing on the fascia.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 06/08/2020.One open sample was received for analysis.During the visual inspection of unused opened sample, the swage and attachment area were not observed as expected; since the hit of the stake was not present at the swage area of needle; causing that suture was detached from the needle.In addition, the suture was examined, and the insertion end could not be observed.The manufacturing records could not be reviewed as the batch number is unknown.Per the sample condition the assignable cause is an incorrect swage defect.

• 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: 10001645
• Report Number: 2210968-2020-03523
• Device Sequence Number: 11505295
• 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): 04/14/2020

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 Model Number: SXPP1A302
• Device Catalogue Number: SXPP1A302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 06/08/2020
• Patient Sequence Number: 1