MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 2-0 S/A CTB-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	ZB345
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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.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 unknown surgery on an unknown date and suture was used.During the procedure, the suture broke.Usage was stopped and another product was used with no problem.The lot number is unknown.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 11/10/2020.Investigation summary: it was reported that the suture was broken during use.One empty labeled winding former, a needle and one suture of product code zb345 were received for analysis.During the visual inspection of opened sample, the swage and attachment area were not observed as expected; since the hit of the stake was on the edge of needle, causing that the suture was severely cut resulting in a clip off.The manufacturing records could not be reviewed as the batch number is unknown.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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 36IN 2-0 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: 10555414
• Report Number: 2210968-2020-07092
• Device Sequence Number: 2445404
• Product Code: NEW
• UDI-Device Identifier: 10705031062030
• UDI-Public: 10705031062030
• 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): 09/10/2020

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: ZB345
• Device Catalogue Number: ZB345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 11/10/2020
• Patient Sequence Number: 1