MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 96IN 1 S/A XLH LP; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z881G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
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.A manufacturing record evaluation was performed for the finished device lot number qmmcdk and no non-conformances related to the reported complaint condition were identified.(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.
Event or Problem Description
It was reported that a patient underwent a gastric tumor resection on (b)(6) 2021 and suture was used.During the procedure, the suture broke while closing the fascia.A new suture was used to complete the case with no adverse patient consequences.No additional information was provided.

• Brand Name: PDSII VIO 96IN 1 S/A XLH LP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12301321
• Report Number: 2210968-2021-07170
• Device Sequence Number: 3841877
• Product Code: NEW
• UDI-Device Identifier: 10705031061927
• UDI-Public: 10705031061927
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,health
• 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: 10/31/2025
• Device Model Number: Z881G
• Device Catalogue Number: Z881G
• Device Lot Number: QMMCDK
• 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: 08/10/2021
• Patient Sequence Number: 1