MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 2-0 S/A CP-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z466H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the suture broke and it was noted that the suture did not have the same tensile strength it normally does.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint number: (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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: procedure name and date? did the operating surgeon observe any suture deficiency or anomaly before, during or after the suture placement? what is the current condition of the patient? how was the product stored? was the integrity of the seal compromised? did the packaging look damaged? where there any quality issues noted prior to the packaging being handled? please confirm that there was no adverse patient outcome device return status/follow up? 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.

• Brand Name: PDSII VIO 27IN 2-0 S/A CP-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• 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
• MDR Report Key: 13284562
• Report Number: 2210968-2022-00481
• Device Sequence Number: 4872701
• Product Code: NEW
• UDI-Device Identifier: 10705031061057
• UDI-Public: 10705031061057
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2022

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 Expiration Date: 04/30/2026
• Device Model Number: Z466H
• Device Catalogue Number: Z466H
• Device Lot Number: REMAXP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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