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

Model Number	ZB340
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
(b)(4).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.
Event or Problem Description
It was reported that a patient underwent an ob-gyn procedure on an unknown date; and a suture was used.During the procedure, the suture pulled off the needle easily while closing the surgical wound on the fascia.It was not a control release needle.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Additional information received: procedure name: cesarean section.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 07/24/2020 additional information: d10 h3 evaluation: an empty labeled winding former and a detached needle was received for analysis.During the visual inspection of detached needles, the swage and attachment area were noted to be as expected, no suture remnant was observed into the barrel hole and the suture was not received to determine the assignable cause.The manufacturing records could not be reviewed as the batch number is unknown per the sample condition, it could not be determined what may have caused the reported incident.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PDSII VIO 27IN 0 S/A CTB-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10153221
• Report Number: 2210968-2020-04568
• Device Sequence Number: 16594229
• Product Code: NEW
• UDI-Device Identifier: 10705031062023
• UDI-Public: 10705031062023
• 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,Followup
• Report Date (Section B): 06/05/2020

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 Model Number: ZB340
• Device Catalogue Number: ZB340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/23/2020; 07/09/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 06/24/2020; 07/24/2020
• Patient Sequence Number: 1