MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 27IN 4-0 S/A PS-1 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y935H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 investigation summary: one open box with twenty-six unopen samples of product code y935h, lot rpmjlk were returned for analysis.Visual inspection and functional testing were conducted on the returned device.As per the sampling plan, a visual inspection was performed on thirteen samples, no defects were fund on the packages.The packets were opened, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strand no anomalies were observed during evaluation.Functional test was performed, and the pull force result were above the minimum requirements.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.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Additional information was requested, and the following was obtained: i am not a doctor, my position is inventory control specialist.This suture issue was reported to me by the surgical team that was in the room during the case.I then reached out to my rep with the vendor, who sent it up the chain.There were 3 needles take consecutively from the box that pulled off the suture.No other events were reported to my knowledge.Related to: 2210968-2022-05400, 2210968-2022-06460.
Event or Problem Description
It was reported that a patient underwent an unknown procedure in 2022 and suture was used.During the procedure, it was reported to the distributor by the customer that the needles are pulling off the suture.There were 3 needles take consecutively from the box that pulled off the suture.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: MCRYL UD 27IN 4-0 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; avenida de las torres 7125; col salvacar; cuidad juarez ; MX
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15198567
• Report Number: 2210968-2022-06458
• Device Sequence Number: 2162427
• Product Code: GAN
• UDI-Device Identifier: 10705031059894
• UDI-Public: 10705031059894
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2022

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: Y935H
• Device Catalogue Number: Y935H
• Device Lot Number: RPMJLK
• 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: 08/08/2022
• Initial Report FDA Received Date: 08/10/2022
• Date Device Manufactured: 12/29/2021
• 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