MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 6 S/A CCS; SUTURE, NONABSORBABLE, STEEL

Catalog Number M654G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation summary: an unopened sample of product code m654, lot # paj146 was returned for evaluation.During the visual inspection of an unopened sample, no defects were found on the package.The sample was opened, and the packet contains four strands, the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects or damaged on the surface were observed.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 performance surface related defect ¿ suture or medical patient related were found.Additional information was requested and the following was obtained: the doctor does not think the steel wires were correlated to the infection.The doctor thinks there is some change in the steel wire and it is relaxing or stretching after it is placed.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.What was the date and name of the initial procedure? the patient demographic info: age, gender, weight, bmi at the time of index procedure.The diagnosis and indication for the index surgical procedure? date - time of onset of infection from the surgical procedure? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? were cultures performed? results? other relevant patient history/concomitant medications.Did the same surgeon who placed the steel suture reapproximate the steel suture? does the surgeon believe the infection was due to any deficiency of the steel suture? what is the patient¿s current status? representative sample returned to support investigation of 3 device issues captured in reports 2210968-2019-84264 and 2210968-2019-84265.Analysis results have been included in reports for each.

Event Description

It was reported that a patient underwent a sternum closure on an unknown date and suture was used.Following the procedure, the patient returned an unknown number of days later, with a superficial infection.The doctor reoperated on the patient, reopened the incision, washed out the wound, noticed the steel wire suture was loose and tightened the loose suture.The patient was discharged.Additional information has been requested.

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device batch paj146, m654g39 and no non-conformances were identified.

• Brand Name: STLESS STEEL SIL 4X18IN 6 S/A CCS
• Type of Device: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8791277
• MDR Text Key: 151103399
• Report Number: 2210968-2019-84294
• Device Sequence Number: 1
• Product Code: GAQ
• UDI-Device Identifier: 10705031000063
• UDI-Public: 10705031000063
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/21/2023
• Device Catalogue Number: M654G
• Device Lot Number: PAJ146
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention