MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 9IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Catalog Number	SXPP1A419
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (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 an unknown procedure in 2019 and barbed suture was used.The needle broke in half while passing through tissue.The needle was retrieved from the patient and another like device was used.It was not reported how the procedure was completed.There were no patient consequences reported.
Additional Manufacturer Narrative
A manufacturing record evaluation was performed for the finished device mm6944, and no non-conformances were identified.Additional summary: received eight unopened samples of product code sxpp1a419, lot mm6944 for evaluation.The complaint sample was not returned.During the visual inspection of samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.No needles breakage was observed.The sutures were dispensed without problems and examined along of the strand and no defects were observed.Also, the samples were tested by resistance test to needle and met the requirements.Per the conditions of the sample received, no performance breakage needle were found, representative samples returned to support investigation of 4 quantity of device issues captured in reports 2210968-2019-88228, 2210968-2019-88230 and 2210968-2019-88232.Analysis results have been included in follow-up reports for each.

• Brand Name: STFX SYM PDS+ UNI VIO 9IN 2-0 S/A SH
• 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: 9135496
• Report Number: 2210968-2019-88231
• Device Sequence Number: 3007504
• Product Code: NEW
• UDI-Device Identifier: 10705031245259
• UDI-Public: 10705031245259
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 10/31/2020
• Device Catalogue Number: SXPP1A419
• Device Lot Number: MM6944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 11/05/2019
• Patient Sequence Number: 1