MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 1 S/A CTX; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z371T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The review of the batch manufacturing records was conducted, and the batch met all finished goods release criteria.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on unknown date and the suture was used.It was also reported that during the surgery, it was found that the needle had been detached from the suture.It was not a control release needle.There were no patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional evaluation summary: the actual sample was returned for evaluation.It was received for analysis an empty opened folder, a detached needle and a dispensed suture of product code z371.During the visual inspection of the needle the swage and attachment area were as expected.The barrel hole of the needle was examined and no suture remnant was noted.The suture was examined, and the insertion did not meet the requirement.The manufacturing records could not be reviewed as the batch number is unknown.Per the sample condition, the assignable cause is a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keeping the needle/suture union during transportation or use.

• Brand Name: PDSII VIO 36IN 1 S/A CTX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8838419
• Report Number: 2210968-2019-84812
• Device Sequence Number: 14050746
• Product Code: NEW
• UDI-Device Identifier: 10705031060821
• UDI-Public: 10705031060821
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

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 Catalogue Number: Z371T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 09/10/2019
• Patient Sequence Number: 1