MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 36"(90CM) 3-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y527H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure (b)(6) 2022 and suture was used.During the procedure, the needle got detached from the suture easily.It was not a control release needle.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Component code: (b)(4) device not returned.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts have been made to retrieve the device.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.The following information was requested, but unavailable: when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling or during use on the patient)? please specify no further information is available.Please provide the lot number: no further information is available.Device return status: we regularly contact with sales rep about the device returning.No further information will be provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 06/20/2022.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.H3 investigation summary: the product was returned for evaluation.Visual inspection was conducted on the returned sample.One empty opened foil packet, an empty labeled winding former, and a detached needle of product code y527h were returned to ethicon for analysis.The suture was not received for evaluation.In order to evaluate the conditions of the returned sample, the swage area and hole of the needle were noted with marks that appear to be by a surgical instrument, and the hole of the needle was crushed.A functional test was not performed, due to the needle was received detached from the suture.The condition of the sample received indicates improper handling of the device.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.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 quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.,according to the information received, the needle was detached from the suture easily.The product was returned t for evaluation.Visual inspection was conducted on the returned sample.Two empty opened foil packets, an empty labeled winding former, and two needle-suture pieces of product code y527h were returned to ethicon for analysis.The suture was not received for evaluation.In order to evaluate the conditions of the returned samples, the swage and attachment area was noted with marks and a suture piece still was attached to the barrel hole needle and the suture end was cut by a sharp edge.No needle pull-off was observed.A functional test was not performed, due to the condition of the sample received.The condition of the sample received indicates improper handling of the device.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.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 quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: MONOCRYL SUTURE 36"(90CM) 3-0 VIO
• 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
• MDR Report Key: 14282700
• Report Number: 2210968-2022-03269
• Device Sequence Number: 15085036
• Product Code: GAN
• UDI-Device Identifier: 10705031059450
• UDI-Public: 10705031059450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2022

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: Y527H
• Device Catalogue Number: Y527H
• 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: 04/06/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/20/2022
• 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