MAUDE Adverse Event Report: ETHICON INC. STFX SPI PDS+ UNI VIO 18IN 2 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1B430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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 the patient underwent an unknown procedure on an unknown date and suture was used.The suture was broken during the procedure.There were no consequences for the patient reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 01/15/2020.Additional information was requested and the following was obtained: is the device being returned? unfortunately product has been discarded and won`t be return for evaluation.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda; 01/22/2020.A manufacturing record evaluation was performed for the finished device lot paj282, and no non-conformances were identified.

• Brand Name: STFX SPI PDS+ UNI VIO 18IN 2 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: 9461332
• Report Number: 2210968-2019-90851
• Device Sequence Number: 19593051
• Product Code: NEW
• UDI-Device Identifier: 10705031235823
• UDI-Public: 10705031235823
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: NA
• 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,Followup
• Report Date (Section B): 11/21/2019

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: 12/31/2020
• Device Model Number: SXPP1B430
• Device Catalogue Number: SXPP1B430
• Device Lot Number: PAJ282
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 12/23/2019; 01/16/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/15/2020; 01/22/2020
• Patient Sequence Number: 1