MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 30IN 7-0 D/A BV-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z135H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide procedure name and date.Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail.How was procedure successfully completed? a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2021 and suture was used.During the procedure, the suture broke when stretched.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDSII VIO 30IN 7-0 D/A BV-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12280051
• Report Number: 2210968-2021-07026
• Device Sequence Number: 4664452
• Product Code: NEW
• UDI-Device Identifier: 10705031060241
• UDI-Public: 10705031060241
• 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): 07/13/2021

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: 01/31/2024
• Device Model Number: Z135H
• Device Catalogue Number: Z135H
• Device Lot Number: PBM794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1