MAUDE Adverse Event Report: ETHICON INC. STRATAFIX PDS PLUS 18"(45CM) 2/0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A408
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported that a patient underwent an unknown cardiovascular procedure on (b)(6) 2018 and suture was used.After placing a few stitches on the tissue, the needle was detached from the suture.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Pc-(b)(4).A detached needle, a suture piece and one empty labeled winding former were returned for evaluation.During the visual inspection of the needle the swage and attachment area were as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted.The suture was examined and the insertion end was measured and did not meet the requirement.Per the sample condition, the assignable cause of the performance - pull off suture needle is a short insertion.This defect is caused because the insertion of the suture in the needle was insufficient from keep the needle/suture union during transportation or use.

• Brand Name: STRATAFIX PDS PLUS 18"(45CM) 2/0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7229904
• Report Number: 2210968-2018-70519
• Device Sequence Number: 11018735
• Product Code: NEW
• UDI-Device Identifier: 10705031219335
• UDI-Public: 10705031219335
• Combination Product (Y/N): N
• PMA/510(K) Number: K113004
• 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): 01/12/2018

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 Catalogue Number: SXPP1A408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1