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 Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Needle analysis: a failed suture needle, labeled as (b)(4), was submitted for fractographic evaluation.The components was identified as product code z513g.It was requested that assess the fracture mode of the failure.A fracture was observed both at the tip (sample b) and suture attachment (sample a) on the needle.The needle was received in one piece.The mating fracture surface of the tip was not provided for this evaluation and the suture end was still partially attached.A scanning electron microscope was used to examine the fracture surfaces and surrounding area of the needles.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The evaluation of (b)(4) revealed the fractures were composed of microvoid coalescence, which is evidence of a ductile overload failure.These were ductile fractures.,according to the information received, the needle tip was unpolished.One labeled winding former, a needle-suture piece, and a suture piece of product code z513g were returned to ethicon for analysis.Visual inspection was conducted on the returned sample.Upon visual analysis of the returned needle revealed that the swage and attachment area was noted to be as expected, however, the tip 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and suture was used.Before use on the patient, it was reported by a sales rep that, during an unknown surgery, when the package was opened, although it should be reverse cutting needle, the needle tip was unpolished.Upon evaluation of the returned sample, a fracture was observed both at the tip and suture attachment on the needle.The needle was received in one piece.The mating fracture surface of the tip was not provided for this evaluation and the suture end was still partially attached.No adverse patient consequences were reported.No additional information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 8/5/2022.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and fractographic testing were conducted on the returned device.Upon visual analysis of the returned sample of product code z513g, a fracture was observed at the tip of the needle.A scanning electron microscope (sem) 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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: 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 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.

• 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
• MDR Report Key: 14684735
• MDR Text Key: 301919287
• Report Number: 2210968-2022-04530
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

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
• Device Operator: Health Professional
• Device Model Number: Z513G
• Device Catalogue Number: Z513G
• Device Lot Number: RJMHTZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2021
• 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