MAUDE Adverse Event Report: ETHICON INC. PDSII SUT 27IN(70CM) 3-0 CLR; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z423H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Investigation summary: it was reported: suture breakage.An opened box with twenty unopened samples of product code z423, lot # kj2343 were received for evaluation.The issue sample was not returned for analysis.During the visual inspection of thirteen unopened samples, no defects were observed on the packets.The samples were opened and the swage and attachment area were noted to be as expected.The sutures were examined along of strand and no defects or damage was noted.A functional test was performed on the samples and the tensile force met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no suture breakage was observed and the tested sample meet the finished goods requirements.
Event or Problem Description
It was reported that a patient underwent an excision of a basil cancer cell procedure on (b)(6) 2018 and suture was used.While suturing deep tissue in an interrupted loop, the suture broke while tying the knot.A second like suture was tried.There were no patient consequences reported.

• Brand Name: PDSII SUT 27IN(70CM) 3-0 CLR
• 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: 8359373
• Report Number: 2210968-2019-78987
• Device Sequence Number: 2137886
• Product Code: NEW
• UDI-Device Identifier: 10705031060913
• UDI-Public: 10705031060913
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/28/2019

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 Expiration Date: 07/31/2021
• Device Catalogue Number: Z423H
• Device Lot Number: KJ2343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/21/2019
• Patient Sequence Number: 1