MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN 0 S/A CTB CR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDPB750D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Additional information was requested, and the following was obtained: did the suture separated from the needle (pull off) during the surgery? not sure what is meant by ""attached to a split eye needle and used"" please explain in more detail.The suture separated from the needle (pull off) during the surgery.The surgeon attached the separated suture to an ""split-eye needle,"" and used the suture with the split-eye needle.What tissue/location was suturing when pull off occurred? no further information is available.Were there any unexpected outcomes or complications as a result of this suture needle pull off event? no further information is available.No further information will be provided.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.(b)(4).
Event or Problem Description
It was reported that a patient underwent a sigmoidectomy procedure on (b)(6) 2021 and suture was used.During the procedure, on the abdominal fascia by interrupted suturing, the suture was detached from the needle easily.It was a control release needle.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDS PLUS VIO 8X18IN 0 S/A CTB CR
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11701118
• Report Number: 2210968-2021-03586
• Device Sequence Number: 19763350
• Product Code: NEW
• UDI-Device Identifier: 10705031218833
• UDI-Public: 10705031218833
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• 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): 03/29/2021

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: 07/31/2022
• Device Catalogue Number: PDPB750D
• Device Lot Number: QJMAZZ
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1