MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z317H
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2019
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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify "the suture became thinner from the middle of it": did the suture fray in the middle? or was the suture strand thinner in the middle than the rest of the suture?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.While using the needle-suture, it was noticed that the suture became thinner from the middle of it.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 1/24/2020.Additional information was requested and the following was obtained: please clarify ""the suture became thinner from the middle of it"": a part of the suture was thinner than the rest of the suture.The position and length of the ""thinner part"" of the suture is unknown.Did the suture fray in the middle?: please see the above answer.Or was the suture strand thinner in the middle than the rest of the suture?: please see the above answer.No further information will be provided.

• Brand Name: PDSII VIO 27IN 2-0 S/A SH
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9555198
• Report Number: 2210968-2020-00132
• Device Sequence Number: 11296101
• Product Code: NEW
• UDI-Device Identifier: 10705031060494
• UDI-Public: 10705031060494
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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): 12/11/2019

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 Model Number: Z317H
• Device Catalogue Number: Z317H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1