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

Catalog Number	SXPP1A402
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: investigation summary: it was reported assembly missing component / incorrect quantity.An empty opened foil, an empty labeled winding former and a needle-suture combination of product code sxpp1a402, lot lgz422 were returned for analysis.During the visual inspection of needle/suture under magnification, slightly marks on the body of the needle that appears to be by use of surgical instruments could be observed.In addition, body fluids in the barbs were found.No defects or damaged on the barbs were noted.However, the two sides of the fixation tab were broken.To seat the fixation tab; pull the device through the tissue to gently seat the fixation tab against the tissue.The fixation tab should be seated above the tissue plane and be visible.Do not exert additional force on the fixation tab.Per the sample condition, the assignable cause of performance - fixation feature breakage it could not be determined what may have caused the reported incident of: ¿ it was found that the suture did not have a fixation tab from the beginning".A manufacturing record evaluation was performed for the finished device lgz422 number, and no non-conformances were identified.
Event or Problem Description
It was reported that the patient underwent an orthopedic procedure on (b)(6) 2019 and barbed suture was used.The staff reported that the suture did not have a fixation tab attached from the beginning.There were no adverse patient consequences reported.Upon evaluation, no defects or damaged on the barbs were noted.However, the two sides of the fixation tab were broken.No additional information was provided.

• Brand Name: SFX SYM PDS+ VIO 18IN 0 S/A CTX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8600356
• Report Number: 2210968-2019-81273
• Device Sequence Number: 2294487
• Product Code: NEW
• UDI-Device Identifier: 10705031218741
• UDI-Public: 10705031218741
• Combination Product (Y/N): N
• 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): 04/15/2019

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: 05/31/2019
• Device Catalogue Number: SXPP1A402
• Device Lot Number: LGZ422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1