MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 27IN 3-0 S/A FS-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z442H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.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.Please confirm, one suture was found broken in the package before the surgery? yes / no.One suture was broken when surgeon seamed in the middle meaning during surgery? yes / no.What was used to complete the procedure? what tissue was being approximated or sutured when it broke? procedure name and date? event date? lot number?.
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, when the surgeon seamed in the middle, the suture broke.There were no adverse patient consequences.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 07/07/2021.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.Additional information was requested and the following was obtained: one suture was found broken in the package before the surgery? yes.One suture was broken when surgeon seamed in the middle meaning during surgery? yes.What was used to complete the procedure? another package of suture.What tissue was being approximated or sutured when it broke? unknown.Procedure name and date? unknown.Event date? unknown.Lot number? unknown.

• Brand Name: PDSII CLR 27IN 3-0 S/A FS-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11838196
• Report Number: 2210968-2021-04713
• Device Sequence Number: 1060494
• Product Code: NEW
• UDI-Device Identifier: 10705031060975
• UDI-Public: 10705031060975
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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 Model Number: Z442H
• Device Catalogue Number: Z442H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/07/2021
• Patient Sequence Number: 1