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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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: what was the size of the needle used? 19mm.The following information was requested, but unavailable: was the needle piece(s) retrieved during the same procedure? no further information is available.Was there any additional tissue damage as a result of searching for the needle piece? no further information is available.What is current condition of the patient? no further information is available.Was more than half the needle retained in the patient? no further information is available.Do you have a photo for visual analysis? no photos are available.No further information will be provided.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the needle could not be passed through the tissue.When it was checked, there was no needle tip.No adverse patient consequences were reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 3/2/2022.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 6/9/2022.H3 investigational summary: one empty opened foil packet, a paper lid, an empty winding former a needle-suture piece, and a suture piece of product code z513g were returned to ethicon inc for analysis.Upon visual analysis of the returned sample revealed that the swage and attachment were noted to be as expected, the needle was examined, and the tip of the needle is not present since was miss-formed.Based on the information currently available, the missing needle tip 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.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: 08/04/2022.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, 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.Additional information:  g1 product complaint # (b)(4).Date sent to the fda: 08/04/2022.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, 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.Corrected information: h6 type of investigation code: b14, b01, h6 investigation findings code: c1601, c070603.H6 investigation conclusions code: d15.Corrected h3 evaluation: the product was returned for evaluation.Visual inspection and fractographic testing were conducted on the returned device.Upon visual analysis of the returned sample of product, a fracture was observed at the tip of the needle.A microscope was used to examine the fracture surfaces and surrounding area of the needle.No conclusion could be reached as to what caused the damage observed on the needle tip.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.

• 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.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 13120206
• MDR Text Key: 285412997
• Report Number: 2210968-2021-13085
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2022

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
• Device Lot Number: RJMDTR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• 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