MAUDE Adverse Event Report: ETHICON INC. EB EXC GRN 36IN 3-0 D/A SH-1; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	X762H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 7/26/2024.H6 component code: g07002 - device not returned.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: ¿ please provide lot number.¿ were there any patient consequences? ¿ did any needle piece fall into the patient? if yes, was the needle piece(s) retrieved during the same procedure? were x-rays taken to locate the needle piece(s)? what measures were taken to retrieve the broken piece? was there any additional tissue damage as a result of searching for the needle piece? if not retrieved, in what tissue structure the broken needle was retained? is there any plan in place to remove the needle piece in the future? please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.Please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep or loc/bq) additional information receives indicates that there have been multiple cases of needle breakage.Have the cases been previously reported to ethicon? if yes, please provide the complaint numbers.If they have not been reported prior, please provide the following for each additional case: procedure date: type of procedure: product name: product code: product lot number: the following information was received: the doctor said that "it was occurred during onlay mesh deployment of the anterior approach.When suturing and fixing a mesh to the hard part of the pubic tuberosity, the suture partner in the narrow space is originally hard tissue, so i have seen cases of needle breakage in my experience, not only with ethibond.I think the cause is that the needle was held in an unreasonable position and inserted at an unreasonable angle.I do not believe this is the fault of the product.I believe that no disadvantage was caused to the patient because the operation time was not extended".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.
Event or Problem Description
It was reported that a patient underwent a hernia repair on (b)(6) 2024 and suture was used.During a hernia surgery, the needle was broken during the surgery on june 25.It was not a control release needle.There were no adverse consequences to the patient.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/23/2024.H3 investigational summary: the product received for analysis was identified as product code x762h.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the suture attachment of the needle.The needle was received in two pieces, only one of the mating fracture surfaces was examined for this evaluation.The needle was noted with marks that appears to be by surgical instrument.A scanning electron microscope 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 the sample revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.The evidence of this examination indicates that the breakage occurred at the attachment area of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.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: EB EXC GRN 36IN 3-0 D/A SH-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19839982
• Report Number: 2210968-2024-07705
• Device Sequence Number: 17834882
• Product Code: GAT
• UDI-Device Identifier: 10705031057920
• UDI-Public: 10705031057920
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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 Catalogue Number: X762H
• 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: 06/29/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown