MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 3-0 S/A FS-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z452G
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a feline underwent a spay procedure on (b)(6) 2021 and suture was used.During the procedure, the needle detached from the suture.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot number remaqp and no non-conformances related to the reported complaint condition were identified investigation summary: one opened foil packet, a labeled winding former, a needle, and a suture piece product code z452 were returned to ethicon inc for analysis.Upon visual analysis of the returned sample revealed that clip off defect was observed in the sample.The barrel hole was examined under magnification and revealed a remnant suture.In addition, the extreme suture was noted to be severely cut.As per returned conditions of the sample no functional test was performed.The clip off defect observed during the visual assessment has been correlated to the manufacturing process.This defect is caused by excessive pressure on the suture during swaging of the needle and consequently breaking.Based on the information currently available, the clip off was identified during the investigation of the sample received.Additional information was requested and the following was obtained: 1.When did the needle got separated from the suture, before use on patient (pre-op), during use on patient (intra-op)? intra -op.2.How was procedure successfully completed? by using a new suture pack.3.Please provide status of product return.Retuned.

• Brand Name: PDSII VIO 27IN 3-0 S/A FS-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12465524
• Report Number: 2210968-2021-08386
• Device Sequence Number: 3924749
• Product Code: NEW
• UDI-Device Identifier: 10705031218703
• UDI-Public: 10705031218703
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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: 04/30/2026
• Device Model Number: Z452G
• Device Catalogue Number: Z452G
• Device Lot Number: REMAQP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/13/2021
• Patient Sequence Number: 1