MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 3-0 S/A PS-1 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y936H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: was surgery delayed due to the reported event? unknown, was procedure successfully completed? yes, were fragments generated? yes, if yes, were they removed easily without additional intervention? yes, patient status/ outcome / consequences, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study unknown.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Was there any adverse consequence associated with the patient? 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? please perform and document the follow up attempt for product return please provide the source or name of person providing answers to follow-up questions a manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.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.
Event or Problem Description
It was reported a patient underwent an lap hysterectomy procedure on (b)(6) 2024 and suture was used.The tip of the needle broken during port closure.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information has been requested however not received.1.Was there any adverse consequence associated with the patient? ans: no.2.Was the needle piece(s) retrieved during the same procedure? ans: yes.3.Were x-rays taken to locate the needle piece(s)? ans: no.4.What measures were taken to retrieve the broken piece? ans: no specific measures, just search, found and remove.5.Was there any additional tissue damage as a result of searching for the needle piece? ans: no.6.Please perform and document the follow up attempt for product return.Ans: device will be shipped to cg labs by 24 jan 2025 according to weekly schedule.7.Please provide the source or name of person providing answers to follow-up questions (not the person relaying/submitting answers to loc or chu).Ans: nurse.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.
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.Additional h3 investigation summary: a failed suture needle was submitted for fractographic evaluation.The component was identified as product code y936h.According to the information, it was reported tip of the needle broken during port closure.The product received for analysis was y936h.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.Visual inspection and metallurgical analysis were performed on the returned product.A fracture was observed at the tip of the needle.One side of the needle was received, the mating fracture surface was not provided 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 evidence of this examination indicates that the breakage occurred at the tip of the needle during use due to tensile overload.There is no evidence of any material flaw or defect that would cause premature failure.The evaluation revealed the fracture was composed of microvoid coalescence, which is evidence of a ductile fracture mode.This was a ductile fracture.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: MCRYL UD 27IN 3-0 S/A PS-1 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; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21179162
• Report Number: 2210968-2025-00706
• Device Sequence Number: 19899297
• Product Code: GAN
• UDI-Device Identifier: 10705031059917
• UDI-Public: (01)10705031059917(17)280531(10)TGMLHU
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2025

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: Y936H
• Device Lot Number: TGMLHU
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: 01/21/2025; 02/07/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 01/31/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Weight: 123 KG