MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 30IN 6-0 D/A BV; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z123H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.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 an unknown procedure on (b)(6) 2021 and suture was used.During the procedure, the needle broke.There were no patient consequences reported.No additional information was provided.

• Brand Name: PDSII VIO 30IN 6-0 D/A BV
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12298403
• Report Number: 2210968-2021-07151
• Device Sequence Number: 3901058
• Product Code: NEW
• UDI-Device Identifier: 10705031060180
• UDI-Public: 10705031060180
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 09/30/2025
• Device Model Number: Z123H
• Device Catalogue Number: Z123H
• Device Lot Number: QLMBEC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1