MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 27IN 3-0 S/A FS-2; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z423H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
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.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.Additional information was requested and the following was obtained: could you please specify what was the reported malfunction that occurred with the needle? during a surgery with a patient the end of the suture broke away from the end of the needle while the doctor was suturing.Did the needle pulled off from suture? did the needle broke? during a surgery with a patient the end of the suture broke away from the end of the needle while the doctor was suturing.Was the needle dull? did the needle bent during the procedure? during a surgery with a patient the end of the suture broke away from the end of the needle while the doctor was suturing.Could you please provide the lot number? lot: qcmdam.Exp: 2025-02-25.Purchased in february.Was the procedure completed successfully? we used another suture to complete the surgery without any issue.Event date? the incident happened on (b)(6) 2021.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.
Event or Problem Description
It was reported that a patient underwent a dermatology procedure on (b)(6) 2021 and suture was used.During the procedure, the end of the suture broke away from the end of the needle while suturing.Another like device was used to complete the procedure.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII CLR 27IN 3-0 S/A FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11896150
• Report Number: 2210968-2021-04991
• Device Sequence Number: 3541001
• Product Code: NEW
• UDI-Device Identifier: 10705031060913
• UDI-Public: 10705031060913
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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 Expiration Date: 02/25/2025
• Device Model Number: Z423H
• Device Catalogue Number: Z423H
• Device Lot Number: QCMDAM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1