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

Model Number	Y845G
Medical Device Problem Code	Component Misassembled (4004)
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.The following information was requested, but unknown: was there any patient consequence reported? how was the procedure completed? did the event occur during one or multiple patient procedures? what is the total number of procedures? was surgery delayed due to the reported event? was procedure successfully completed? were fragments generated? if yes, were they removed easily without additional intervention? was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required? analysis summary: one empty opened box, and nine samples of product code y845 were returned to ethicon for evaluation.Visual inspection was conducted on the returned devices.Upon visual inspection of the returned samples, the information printing on the foils of the needle, shows a conventional cutting needle, sales type pc-3, needle length 16 mm, 3/8 circle.A further investigation was performed, and the graphics used in each lot number are correct according to manufacturing dates and finished drawing.In addition, the needle rmc assigned to these lots number is (ns-0508) needle sales type pc-3, 3/8 circle, conventional cutting, wire diameter 18 mils and needle length 16 mm.The needles were measured in diameter and meet the ethicon requirements.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date in 2022 and suture was used.The needle size on the packaging was 16mm, but the surgeons believed the needle was 13mm.There were no adverse patient consequences.Additional information was requested.

• Brand Name: MCRYL UD 18IN 4-0 S/A PC-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: 14885279
• Report Number: 2210968-2022-05041
• Device Sequence Number: 14999365
• Product Code: GAN
• UDI-Device Identifier: 10705031059740
• UDI-Public: 10705031059740
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/01/2022

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 Model Number: Y845G
• Device Catalogue Number: Y845G
• Device Lot Number: RPMCKT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown