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	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.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 laparoscopic myomectomy procedure on (b)(6) 2019 and barbed suture was used.The suture broke apart from the needle during use.The case was completed with a similar device.There were no adverse patient consequences.
Additional Manufacturer Narrative
Product complaint #(b)(4).A manufacturing record evaluation was performed for the finished device mh6473 batch number, and no non-conformances were identified.Device evaluation summary: the actual device was received for evaluation.It was received for analysis a suture piece of product code sxpp1a423, lot mh6473.During the visual inspection of the suture piece, a correct insertion mark was observed and the other extreme was cut.However, the force used to detach needle from the suture could not be determined.In addition, the needle was not return, and we are unable to determine the assignable cause.The manufacturing records were reviewed, and the manufacturing/ packaging criteria were met prior to the release of this batch.Due to that the needle was not received, and condition of suture received, it could not be determined what may have caused the reported incident."two sutures broke apart from the needles" additional device captured in mw 2210968-2019-89402.

• 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
• MDR Report Key: 9268116
• Report Number: 2210968-2019-89401
• Device Sequence Number: 16632058
• Product Code: NEW
• UDI-Device Identifier: 10705031245365
• UDI-Public: 10705031245365
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 06/30/2020
• Device Catalogue Number: SXPP1A423
• Device Lot Number: MH6473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/08/2019
• Supplement Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/03/2019
• Patient Sequence Number: 1