MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number Z347H

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot number qgmjkx, and no non-conformances related to the reported complaint condition were identified.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.

Event Description

It was reported that a patient underwent a hernia procedure on (b)(6) 2020, and suture was used.During the procedure, the tip of the needle broke off inside of the patient.The fragments were retrieved.A new suture was used to complete the case with no adverse patient consequences.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to the fda: 12/18/2020.H6 component code: g07002 - conforming device.A manufacturing record evaluation was performed for the finished device lot number qgmjkx/z347, and no non-conformances related to the reported complaint condition were identified.Additional h3 investigation summary: it was reported that that during a hernia procedure the tip of the needle broke off inside of the patient.A suture needle was returned for evaluation.A fracture was observed at the tip of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage observed coincidental to the fracture provides additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.The evidence of this examination indicates that the breakage occurred at the tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.Additional h3 investigation summary: thirty-six unopened samples of product code z347, lot # qgmjkx were received for evaluation.During the visual inspection of thirteen unopened samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.No needles breakage was observed on body, tip or swage area.The sutures were dispensed without problems and examined along of the strand and no defects were observed.Also, the sample was tested by resistance test to needle and met the requirements.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.The device performed without any defect noted.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PDSII VIO 36IN 1 S/A CT-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10860525
• MDR Text Key: 216961049
• Report Number: 2210968-2020-09109
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031060685
• UDI-Public: 10705031060685
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z347H
• Device Catalogue Number: Z347H
• Device Lot Number: QGMJKX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 12/04/2020
• Patient Sequence Number: 1