MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z339H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number qkmdah and no non-conformances related to the reported complaint condition were identified.Investigation summary: visual analysis of the returned sample revealed that one sample, of product code z339, was received 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.The pull-out has been correlated to the manufacturing process.This defect is caused because the suture was not properly inserted inside of the needle barrel hole resulting in a pull-out defect.Additional information was requested and the following was obtained: procedure name and date? not provided event date? (b)(6) 2021 what was being done when the needle pulled-off (in the package/ removal from package / during passage through tissue)? the needle came off the suture as soon as the vet touched it, didn't even get it out of the packaging.How was the case completed? new suture for surgery.Any adverse patient consequences and what medical/surgical intervention was performed to manage them? no adverse consequence.Was the needle piece removed from the patient during the same procedure? n/a what tissue/location was suturing when pull-off occurred? not provided.Were there any unexpected outcomes or complications as a result of this suture needle pull-off event? the needle came off the suture as soon as the vet touched it, didn't even get it out of the packaging.No adverse consequences other than having to get a new suture for the surgery.
Event or Problem Description
It was reported that an animal underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the needle came off the suture as soon as the vet touched it, didn't even get it out of the packaging.Another like device was used.Upon evaluation of the returned device, short insertion was observed in the strand.No additional information was provided.

• Brand Name: PDSII VIO 27IN 2-0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12543710
• Report Number: 2210968-2021-08928
• Device Sequence Number: 13754346
• Product Code: NEW
• UDI-Device Identifier: 10705031060609
• UDI-Public: 10705031060609
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: 08/31/2025
• Device Model Number: Z339H
• Device Catalogue Number: Z339H
• Device Lot Number: QKMDAH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/28/2021
• Patient Sequence Number: 1