MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 60IN 2-0 S/A CTX LP; SUTURE, SURGICAL, ABSORBABLE

Model Number	D8588
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch, and no non-conformance's were identified.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 a c-section surgery on (b)(6) 2020 and the suture was used.During the procedure, the tip of the needle broke while suturing, unknown layer of tissue, unknown loop.The needle tip was removed from the patient.The procedure was completed using unknown suture.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/24/2020.Additional h3 investigation summary: it was reported breakage needle.One open box with thirteen samples of product code: d8588, lot: pgm885 was received for analysis.The complaint sample was not returned for evaluation.During the visual inspection of samples, no defects were found on the packages.The samples were opened and the swage and attachment area were noted to be as expected; also, the tip and body of the needles were examined under magnification and no defects, damage or needle breakage were found.Additionally, the samples were tested by resistance test to needle and met the requirements.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.According to the samples conditions, no performance, breakage needle was found.

• Brand Name: PDSII VIO 60IN 2-0 S/A CTX LP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9767785
• Report Number: 2210968-2020-01594
• Device Sequence Number: 3308168
• Product Code: NEW
• UDI-Device Identifier: 10705031030626
• UDI-Public: 10705031030626
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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 Expiration Date: 05/31/2024
• Device Model Number: D8588
• Device Catalogue Number: D8588
• Device Lot Number: PGM885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1