MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 30IN 6-0 D/A C-1 VB; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8307H
Medical Device Problem Code	Material Separation (1562)
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).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: g07002.To date it has been reported that the device will not be returned.If the device or further details are received as a later date a supplemental medwatch will be sent.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Could you please clarify if the 57 devices indicated in the "product involved" present the issue "suture needle pull off" please confirm.If multiple devices pulled off, please indicate how many devices pulled off.Did the devices pull off during one procedure or during multiple procedures ? what was the name of the procedure? what was being done when the needle pulled-off (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)? were x-rays taken to locate the needle? was the needle piece removed from the patient during the same procedure? does the needle remain in the patient¿s tissue? "what tissue structure is it located? size of the needle retained are any plans in place to remove the needle piece in future?" if retained, what is the surgeon's opinion of consequences to the patient? was there any patient consequence or injury? what medical/surgical intervention was provided? what is the condition of the patient? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? on what tissue was the suture used? what was the tissue condition (normal, thin, calcified, fragile, diseased)? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? was the wound extended or did the surgeon cut into different tissue when searching for the needle? was the patient treatment or post-operative care altered in anyway due to the prolonged surgery time? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? what is the physician¿s opinion as to the etiology of or contributing factors to this event? lot number? surgeon¿s name? if applicable, will product be returned? if so, please provide the return date and tracking information.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the thread was separated from the needle, which resulted in the extension and search for the needle up to 1 hour.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 3/31/2023.H6 component code: g07002 no device problem found.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The returned sample determined that it was received fifty-five unopened samples that pertain to the product code 8307h.As per the sampling plan, a visual inspection was performed on thirteen samples, the packets were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along the strand no anomalies were observed during the evaluation.A functional test was performed using instron equipment and the pull force result 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.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 Manufacturer Narrative
(b)(4).Date sent to the fda: 2/2/2023.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 was requested, and the following was obtained: what was being done when the needle pulled-off (removal from package / during handling prior to use on patient/ during passage through tissue / during tying / post-op)?by pass were x-rays taken to locate the needle? yes.Was the needle piece removed from the patient during the same procedure? yes does the needle remain in the patient¿s tissue?no."what tissue structure is it located? size of the needle retained vein.Are any plans in place to remove the needle piece in future?" doesn¿t apply.If retained, what is the surgeon's opinion of consequences to the patient? doesn¿t apply was there any patient consequence or injury? what medical/surgical intervention was provided? increased time of operative.What is the condition of the patient? ok.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Was additional dissection required in other tissues other than the target tissue? if yes, please describe.Was the post-operative care altered in anyway due to the prolonged surgery time of 1 hour? if yes, please explain.Was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? lot number? device return status? corrected information: b1, b2, h1 to malfunction.

• Brand Name: PRLNE BLU 30IN 6-0 D/A C-1 VB
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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 PR ; *
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16112048
• Report Number: 2210968-2023-00130
• Device Sequence Number: 5754180
• Product Code: GAW
• UDI-Device Identifier: 10705031014183
• UDI-Public: 10705031014183
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2023

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 Expiration Date: 11/30/2024
• Device Model Number: 8307H
• Device Catalogue Number: 8307H
• Device Lot Number: PPBDCD
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 01/30/2023; 03/24/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/02/2023; 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2019
• 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 Sex: Unknown