MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A UR-6; SUTURE, SURGICAL, ABSORBABLE

Model Number	D6659
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.When taking out the needle-suture from the package after holding the needle with a needle-holder, the needle was detached from the suture.It was not a control release needle.There were no adverse consequences to the patient.During the evaluation a short insertion was observed in the strand.No additional information was provided.
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.Investigation summary: visual analysis of the returned sample revealed that one sample, of product code d6659, was received to ethicon inc for evaluation.After investigation of the sample, short insertion was observed in the strand.The visual inspection concluded that the combination of the needle/suture was found detached since the insertion end of the suture did not meet the requirement.Based on the information currently available, the pull-out was identified during the investigation of the sample received.This product issue will be addressed through ethicon inc¿s quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Device history lot: "a manufacturing record evaluation was performed for the finished device lot number paz296/d6659 and no non-conformances related to the reported complaint condition were identified.

• Brand Name: PDSII VIO 27IN 2-0 S/A UR-6
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12686742
• Report Number: 2210968-2021-10223
• Device Sequence Number: 5414025
• Product Code: NEW
• UDI-Device Identifier: 10705031026636
• UDI-Public: 10705031026636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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: 12/31/2023
• Device Model Number: D6659
• Device Catalogue Number: D6659
• Device Lot Number: PAZ296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1