MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 4 X 30"(75CM) 7-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8703
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Event related to mw # 2210968-2022-02047, mw # 2210968-2022-02039, mw # 2210968-2022-02048, mw # 2210968-2022-02041, mw # 2210968-2022-02042, mw # 2210968-2022-02043, mw # 2210968-2022-02044, mw # 2210968-2022-02045, mw # 2210968-2022-02046.
Event or Problem Description
It was reported that a patient underwent a triple bypass procedure on (b)(6) 2022 and suture was used.The suture broke while suturing the anastomosis on the heart.Surgeon switched his technique purse string and suture to another like device to compete the procedure.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/10/2023.H6 component code: g07002 no device problem found.A device has been received for product code 8703h, lot rjbbha, however clarification is requested whether the product belongs to this complaint.The following additional information was requested: our failure analysis lab received the additional product with reference to this complaint, the following product was received: product code: 8703h.Lot #: rjbbha.1.Could you please clarify if the additional device belongs to this complaint? 1a.If yes, did a device malfunction occur during the same procedure for product code 8703h/lot rjbbha and epm8703/lot rdbbql? 2.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn¿t belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex tracker number.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.H3 investigational summary: the product was returned to ethicon for evaluation.The functional testing was conducted on the returned devices.The returned samples determined that it was received one straight pack with two needle-suture combinations that pertain to the product code epm8703.This product code is multistrand and required four strands double armed per packet.In order to evaluate the condition of two needle sutures, the swage and attachment area was noted to be as expected.The sutures were dispensed without problems and examined along the strand and no issues related to breakage sutures or anomalies were observed during the evaluation.The functional test was performed using instron equipment and the tensile force was above the minimum requirements.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Related reports: 2210968-2022-02038, 2210968-2022-02039, 2210968-2022-02048, 2210968-2022-02041, 2210968-2022-02042, 2210968-2022-02043, 2210968-2022-02044, 2210968-2022-02045, 2210968-2022-02046, 2210968-2022-02047.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Date sent to the fda: 4/6/2023.The following additional information was requested, and no answer was obtained.If any additional information is received, a supplemental medwatch report will be sent.Our failure analysis lab received the additional product with reference to this complaint, the following product was received: product code: 8703h, lot#: rjbbha.1.Could you please clarify if the additional device belongs to this complaint? 1a.If yes, did a device malfunction occur during the same procedure for product code: 8703h/lot: rjbbha and epm8703/lot: rdbbql? 2.If not, could you please clarify if the additional received product belongs to a different complaint? if so, can you please provide the complaint number.3.If the device was not reported before, please provide more details of device malfunction.4.If the product doesn't belong to any complaint, please let us know so we can discard it or advise if the product is required to be returned.5.If you have the correct complaint product in your possession, please forward the product to ethicon as soon as possible.If you have already sent the product to ethicon, please reply to ethwcqcom@its.Jnj.Com with the ups, dhl or fedex tracker number.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.Related reports: 2210968-2022-02038, 2210968-2022-02039, 2210968-2022-02048, 2210968-2022-02041, 2210968-2022-02042, 2210968-2022-02043, 2210968-2022-02044, 2210968-2022-02045, 2210968-2022-02046, 2210968-2022-02047.

• Brand Name: PROLENE SUTURE 4 X 30"(75CM) 7-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13864306
• Report Number: 2210968-2022-02038
• Device Sequence Number: 11941036
• Product Code: GAW
• UDI-Device Identifier: 10705031203587
• UDI-Public: 10705031203587
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2023

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: 03/31/2026
• Device Model Number: EPM8703
• Device Catalogue Number: EPM8703
• Device Lot Number: RDBBQL
• 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: 03/01/2022
• Supplement Date Received by Manufacturer: 03/09/2023; 03/20/2023
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 03/10/2023; 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown