MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z346H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device pek661 batch number, and no non-conformance's were identified.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.Additional information was requested and the following was obtained: were there any unexpected outcomes or complications as a result of the prolonged surgery time? r./ no.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain r./ no.2 devices broke during same procedure.Additional device captured in mw 2210968-2020-00857.
Event or Problem Description
It was reported that the patient underwent a laparotomy procedure on (b)(6) 2019 and suture was used.The suture is broken in the middle of the closure of the abdominal aponeurosis of the patient in a supra umbilical and infraumbilical laparotomy.The procedure was delayed by 60 minutes and completed successfully.There were no adverse patient consequences reported.

• Brand Name: PDSII VIO 36IN 0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9655616
• Report Number: 2210968-2020-00858
• Device Sequence Number: 16858957
• Product Code: NEW
• UDI-Device Identifier: 10705031060661
• UDI-Public: 10705031060661
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 01/13/2020

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: 04/30/2024
• Device Model Number: Z346H
• Device Catalogue Number: Z346H
• Device Lot Number: PEK661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/31/2020
• Patient Sequence Number: 1
• Patient Age: 58 YR