MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 4-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y496G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/5/2024.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, 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.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Additional information was requested, the following was obtained: can you identify the product code and lot number of the product used? previously sent.Were there any patient consequences? no.Did the needle piece fall into the patient? no.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 provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep).(b)(6).Please perform and document the follow-up attempt for product return.Please document the shipment tracking number in the notes or rmao sections.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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.It was reported that the their was a rupture of the tip of the needle when suturing organ.There were no patient consequences reported.Additional information was requested.

• Brand Name: MCRYL UD 18IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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: 20852438
• Report Number: 2210968-2024-12867
• Device Sequence Number: 8100242
• Product Code: GAN
• UDI-Device Identifier: 10705031059375
• UDI-Public: 10705031059375
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 12/05/2024

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: Y496G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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