MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 9IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A423
Medical Device Problem Code	Break (1069)
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 a patient underwent a myomectomy on an unknown date and a barbed suture was used.During the procedure, the suture cut from the swage.The procedure was completed successfully.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 08/14/2019.Additional h-3 summary: a needle of product code sxpp1a423 was returned for evaluation.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined, and no suture remnant was noted.The suture was not returned for evaluation to determine the assignable cause.The manufacturing records couldn¿t be reviewed as the batch number is unknown.Due to condition of the sample, it could not be determined what may have caused the reported incident of: ¿thread cut from swage¿.

• Brand Name: STFX SYM PDS+ UNI VIO 9IN 0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8790136
• Report Number: 2210968-2019-84280
• Device Sequence Number: 2639236
• Product Code: NEW
• UDI-Device Identifier: 10705031245365
• UDI-Public: 10705031245365
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K141776
• 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): 06/20/2019

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 Catalogue Number: SXPP1A423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 08/14/2019
• Patient Sequence Number: 1