MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 4-0 S/A P-3 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y494G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2023 and suture was used.During wound closure, the wound was halfway closed with deep stitches when the needle broke.The wound was then opened up and the broken piece was pulled out.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (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.Component code: (b)(4) device not returned.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 adverse consequence associated with the patient? no - was the needle piece(s) retrieved during the same procedure? yes - were x-rays taken to locate the needle piece(s)? no - what measures were taken to retrieve the broken piece? the sutures that were already placed were removed and the broken piece was taken out - was there any additional tissue damage as a result of searching for the needle piece? no - does a piece of the needle remain in the patient¿s tissue? no.This medwatch report is in response to receipt of a user facility medwatch form: (b)(4).
Additional Manufacturer Narrative
Product complaint # (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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 4/18/2023.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.Additional information: a2, a3, b1.Additional information was requested, and the following was obtained: what instruments were used to grasp the needle? needle driver.Where was the needle grasped during use? ~60% back from the tip.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure: 67 male weight and bmi n/a.Name of index surgical procedure? excision with repair.The diagnosis and indication for the index surgical procedure? basal cell skin cancer, malignant.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? open.On what tissue was the suture used? subcutaneous tissue.What was the tissue condition (normal, thin, calcified, fragile, diseased)? thick.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? no.Other relevant patient history/concomitant medications? n/a.What is the physician¿s opinion as to the etiology of or contributing factors to this event? the back skin was very thick and needle likely bent and broke because of that what is the patient's current status? normal, wound has healed well.Lot number: skmqej.

• Brand Name: MCRYL UD 18IN 4-0 S/A P-3 PRM MP
• 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 ; 9083863534
• MDR Report Key: 16588481
• Report Number: 2210968-2023-01904
• Device Sequence Number: 5729062
• Product Code: GAN
• UDI-Device Identifier: 10705031059337
• UDI-Public: 10705031059337
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Y494G
• Device Catalogue Number: Y494G
• Device Lot Number: SKMQEJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 04/05/2023; 05/02/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/18/2023; 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male