MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 1 S/A UR-6; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	DC303
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional 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: was there any medical or surgical intervention performed (product removed; re-operation; re-closure; drainage)? if so, please specify.Product was removed it was reported that fragments were generated: did the needle fall into the patient? yes, the needle broke in half and the surgeon spent 30+ mins getting it out if yes, were the needle fragments retrieved during the same procedure? yes.Were x-rays taken to locate the needle piece(s)? no.The following information was requested, but unavailable: was there any adverse consequence associated with the patient? unknown.Could you tell me if there was a prescription for steroids or antibiotics for the patient's recovery? if yes, please provide medication name, route and dose.Unknown.What measures were taken to retrieve the broken pieces? unknown.Was there any additional tissue damage as a result of searching for the needle piece? unknown.Does a piece of the needle remain in the patient¿s tissue? none to our knowledge if yes, are any plans in place to remove the needle piece in future? unknown.What tissue structure the broken needle was located? unknown.What is the surgeon's opinion of consequences to the patient? unknown.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.On the surgeon's last pass, the needle broke.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6.Component code: g07002 - device problem not found.Investigation summary: a failed suture needle, labeled as (b)(4), was submitted for fractographic evaluation.The component was identified as product code dc303.It was requested that assess the fracture mode of the failure.A fracture was observed in the body 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 to determine the fracture mode.The evaluation of (b)(4) revealed the fracture was composed predominantly of microvoid coalescence, which is evidence of a ductile fracture mode.Mechanical damage, a cup-and-cone shaped fracture and macroscopic plastic deformation observed coincidental to the fracture provide additional evidence that the failure was induced by mechanical deformation leading to ductile overload.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred from mechanical deformation, indents and scratches, due to gripping, bending and overstressing of the needle.  there is no evidence of any material flaw that would cause premature failure.The needle breakage was confirmed.Nine packets of product code dc303 were returned for analysis with the packaging closed.Upon initial inspection of the samples, no external damages were observed on the packet.In order to evaluate the conditions of the nine samples, the packets were opened, and no defects were detected.The swage and attachment area was noted to be as expected.The needle was intact and no damage, or bending on the body, tip, or swage area were observed during the evaluation.In addition, a functional test was performed, to needle by resistance 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.It should be noted that as part of our quality process, each batch is randomly 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.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: VCL CT BRD UD 27IN 1 S/A UR-6
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14159719
• Report Number: 2210968-2022-02783
• Device Sequence Number: 2944313
• Product Code: GAM
• UDI-Device Identifier: 10705031036185
• UDI-Public: 10705031036185
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: DC303
• Device Catalogue Number: DC303
• Device Lot Number: RCMAPM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown