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

Catalog Number	FZ318H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a left nephrectomy for renal transplantation procedure on (b)(6) 2021 and suture was used.The thread pulled off during the procedure.Another device was used to complete the procedure.
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).Device not returned.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.Additional information was requested and the following was obtained: procedure: left nephrectomy for renal transplantation use of another device to complete the procedure.The correct event date and procedure date is (b)(6) 2021.No patient consequence.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Related medwatch reports: 2210968-2021-08975, 2210968-2021-08976, 2210968-2021-08978.

• Brand Name: PDSII VIO 27IN 0 S/A SH PLUS
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12548837
• Report Number: 2210968-2021-08977
• Device Sequence Number: 5266404
• Product Code: NEW
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2021

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: 01/31/2026
• Device Catalogue Number: FZ318H
• Device Lot Number: RBMHMX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/29/2021
• Patient Sequence Number: 1