MAUDE Adverse Event Report: ETHICON INC. STLESS STEEL SIL 4X18IN 5 S/A V-40; SUTURE, NONABSORBABLE, STEEL

Model Number M650G

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Not Applicable (3189)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: did one suture break post-op or did more than one suture break post-operatively? more than one suture break post-operatively.No additional information is available.The patient demographic info: weight, bmi at the time of index procedure: the patient is (b)(6) years male.His weight is (b)(6) kg.The diagnosis and indication for the index surgical procedure: coronary artery bypass graft and a mitral valve prolapse.On what tissue was the suture used? 2 stitches were put on the manubrium sterni.Also, with regard to the sternum, stitches like ¿8¿ letter were put twice through the intercostal space.How was the suture placed, interrupted or continuous? 2 stitches were put on the manubrium sterni.Also, with regard to the sternum, stitches like ¿8¿ letter were put twice through the intercostal space.Other relevant patient history/concomitant medications: diabetes.What is the patient¿s current status? the patient has been hospitalized.The following information was requested but unavailable: what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how the suture was initially tied? was there any precipitating stress factor for the suture breakage? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement? did a suture break intra-operatively during the index procedure on (b)(6) 2019? lot number? investigation summary: it was reported the suture was broken easily during use.Fourteen used sutures pieces of product code m650g, lot number unknown was received for evaluation.During the visual inspection of sutures pieces, three were received in loop, seven wavy and four were noted with knot technique for steel suture, all presented use marks, body fluids, and the ends were noted with lineal cut that appear to be by surgical instrument.A functional test was performed to three sutures pieces using an instron and the tensile strength were above the minimum requirements.The manufacturing records couldn't be reviewed as the batch number is unknown.The condition of the sample received indicate an improper handling of the device.Investigation summary: multiple suture pieces were evaluated identified as product code m650g.A fracture was observed on both ends of the specimen, they were labeled as side a and side b.A scanning electron microscope (sem) was used to examine the fracture surfaces and surrounding area of the sutures.The fracture surfaces were examined in multiple locations in order to determine the fracture mode.The fracture surface contained mechanical damage, which obscured some of the fine fractographic features.Beachmarks and striations indicative of cyclic loading and incremental crack advancement were observed indicating fatigue.The final fracture zone, was relatively small, an indication of a lower nominal stress failure.Mechanical damage in the form of indents and scratches were observed coincidental to the fracture.The fracture surface contained ratchet marks in two distinct regions initiating from the outer diameter and located approximately 180° apart.Beachmarks and striations indicative of cyclic loading and incremental crack advancement were observed in two regions indicating bidirectional fatigue.The final fracture zone, was relatively small, an indication of a lower nominal stress failure.The fracture surface was oriented perpendicular to the longitudinal axis of the suture.A secondary crack was observed on the side of the suture.The evaluation of (b)(4) revealed the fractures contained striations, ratchet marks and beachmarks, which is evidence of a fatigue failure.Fatigue failure is caused by cyclic loading which leads to crack initiation, progressive growth and then failure.Note: events reported via mw # 2210968-2020-07313.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that the patient underwent a coronary artery bypass graft and a mitral valve prolapse surgery on (b)(6) 2019 and suture was used.The suture was used for wound closure.It was reported that two stitches were put on the manubrium sterni and with regard to the sternum, stitches like ¿8¿ letter were put twice through the intercostal space.On (b)(6) 2020, ct scan was taken due to shaking of the sternal.At that time, it was found that all the sutures had broken.On (b)(6) 2020, the sutures were removed, and re-fixation was performed.When opening the chest, it was found all the sutures had broken into multiple pieces.Thus, all the sutures were retrieved without cutting them.One of the broken pieces had penetrated the diaphragm, and it had moved into the abdominal cavity.Another piece had moved along the pectoralis major muscle fascia, and it had reached to the left side of the chest.Another broken piece had fallen into the longitudinal contour.All the pieces were retrieved.Then, after the refixation, the patient has been hospitalized, and the condition has been getting better properly.It was reported that the surgeon opined there was a causal relationship between the product and the event and the surgeon opined there was a problem with the strength of the suture.It was also reported that the patient has diabetes.No additional information was provided.

Manufacturer Narrative

(b)(4).Date sent to the fda: 11/12/2020.Additional h6 patient code: 3189 ¿ hospitalization for further diagnosis.Note: events reported via mw#: 2210968-2020-07313.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, or its employees that the report constitutes an admission that the product, ethicon, 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.

• Brand Name: STLESS STEEL SIL 4X18IN 5 S/A V-40
• Type of Device: SUTURE, NONABSORBABLE, STEEL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10830860
• MDR Text Key: 216082833
• Report Number: 2210968-2020-08996
• Device Sequence Number: 1
• Product Code: GAQ
• UDI-Device Identifier: 10705031045439
• UDI-Public: 10705031045439
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 11/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M650G
• Device Catalogue Number: M650G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Date Manufacturer Received: 10/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 65