MAUDE Adverse Event Report: ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

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

Patient Problems Hematoma (1884); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.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.Is there any alleged deficiency relating to ethicon suture product? if yes, were the cases discussed in this article previously reported to ethicon? if yes provide complaint reference number? does the author/surgeon believe that the ethicon product involved, caused and / or contributed to any post-op complications or adverse event / patient outcome or consequences described in this article? if yes, provide details of event and specific product code and lot number if available for any of the ethicon devices used? can specific patient demographics be provided for the subject(s) of this article? if so, please also include: pre-existing conditions, exact procedure performed (if not already specified in the literature)? was there any antibiotics-medication/medical treatment provided to patient with superficial wound dehiscence? any specific medical/surgical intervention for patient, post-op after initial procedure to treat superficial wound dehiscence? are there suture devices available to be returned for analysis? (b)(4).

Event Description

It was reported via journal article: title: "repair of middle fossa cerebrospinal fluid leaks using a novel combination of materials: technical note." authors: cedric d.Shorter, m.D., david e.Connor jr., d.O., jai deep thakur, m.D., gale gardner, m.D., anil nanda, m.D., m.P.H., bharat guthikonda, m.D.Citation: neurosurg focus.2012; 32.Doi: http://thejns.Org/doi/abs/10.3171/2012.4.Focus1258.The methods for repairing middle fossa csf (mfcsf) leaks have varied and yielded mixed results.The objective of this study was to evaluate the safety and durability of the authors¿ repair technique using a novel combination of 3 synthetic materials.The authors performed a retrospective case review of patients treated for csf leaks between january 2009 and september 2011.A total of 7 patients (3 men and 4 women; age range: 22 to 81 years old) were found to have undergone middle fossa craniotomies for csf leaks.During the surgical procedure, dural defects, wherever possible, are primarily repaired with nurolon 4-0 running braided monofilament suture (ethicon).The temporalis muscle is reapproximated with vicryl 2-0 suture (ethicon) as is the subsequent galeal layer.Reported complications included case 5, a (b)(6) male patient with epidural hematoma which required surgical evacuation and case 6, a (b)(6) female patient with superficial wound dehiscence.Based on the authors¿ experience, they believed that the use of hac, collagen-based dural substitute matrix, and peg hydrogel sealant via the middle fossa approach, along with routine postoperative lumbar drainage, provides an effective combination for the repair of mfcsf leaks.In the small series, no patient required reoperation for a recurrent csf leak, which justifies continued application and further prospective evaluation of this novel technique.

• Brand Name: NUROLON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7997082
• MDR Text Key: 124798572
• Report Number: 2210968-2018-76711
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention