MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 18IN 4-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number Z513G

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/09/2021

Event Type  malfunction  

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.Attempts have been made to retrieve the device.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.Additional information was requested and the following was obtained: procedure name: cesarean section.During a cesarean section, when the skin layer was closed, suture was performed by instrument tying.From the 1st to the 2nd stitch, the needle could be passed through the tissue smoothly, but after putting the 3rd to the 5th stitch, the surgeon noticed that the needle could not be passed smoothly.So, the surgeon checked the needle, and it might be broken, so the sutured wound was opened once and checked, but the needle tip could not be found.After that, a new needle was used for suturing.There is no particular health hazard at present.

Event Description

It was reported that a patient underwent a c-section procedure on (b)(6) 2021 and suture was used.During the procedure, after putting the 3rd to the 5th stitch, the needle could not be passed smoothly.The needle was checked and it might be broken.The sutured wound was opened once and checked, but the needle tip could not be found.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 1/31/2022.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon inc for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that a paper lid, an empty winding former, and a needle-suture of product code z513g were received for evaluation.Visual inspection of the sample, the swage, and the attachment area was noted to be as expected.No needle breakage was observed on the body, tip, or swage area.However, marks and body fluids were noted.Due to the condition sample, no functional test was performed, to needle by resistance.The manufacturing records couldn't be reviewed as the batch number is unknown.It should be noted that as part of our quality process, the device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Visual analysis of the returned sample determined that on a broken needle at the tip product code z513g was received.Marks on the tip due to the use of the surgical instrument were observed.Additional evaluation is necessary to determine the assignable cause of the breakage needle.Additional evaluation will be conducted on the returned sample.Additional information was requested, the following was obtained: please provide lot number.: no further information is available.What was the size of the needle used? : 19mm.Where is the needle retained; in what structure? : the needle tip was not found.The needle was used for dermis closure.The peritoneum was closed, and there is no possibility of residual intra-abdominal cavity, but there is a possibility of residual in the body.Was x-ray used to locate the needle tip? : no further information is available.Are there plans to remove the retained needle piece? : no further information is available.Were there any patient consequences? : no further information is available.Please provide the status of the device(s) as it has not been received for analysis.If the device has been shipped, please provide the shipment tracking details.: the device has been received at sukagawa and will be shipped.Please check rmao.No further information will be provided.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 3/2/2022.H3 investigational narrative: a failed suture needle was submitted fractographic evaluation.The component was identified as product code z513g.It was requested that assess the fracture mode of the failure.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided for this evaluation.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needle.The fracture surfaces were examined in multiple locations to determine the fracture mode.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.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.In order to avoid this kind of damage grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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 18IN 4-0 S/A PS-2 PRM MP
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13120760
• MDR Text Key: 289428993
• Report Number: 2210968-2021-13088
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031061354
• UDI-Public: 10705031061354
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z513G
• Device Catalogue Number: Z513G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female