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

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

Patient Problem Unspecified Infection (1930)

Event Date 06/10/2022

Event Type  Death  

Event Description

Title: osteocutaneous-flap-related osteomyelitis following mandibular reconstruction: a cohort study of an emerging and complex bone infection the objective of this study is to describe diagnosis, management, and outcome of ocf-related osteomyelitis.Between september 1, 2012 and july 31, 2019, a total of forty-eight patients with mandibular ocf-associated osteomyelitis were included.Thirty of the 48 included patients were male, with a median age of 60.5 years.Ocf-related osteomyelitis was mostly early (n=43/48) and was considered acute in 22/48cases.Fever was present in 17/47 patients.Note that the eight patients with no gold-standard microbiological diagnosis received 92 days of antimicrobials, after a surgery in four patients.Persistent infection was noted in three patients, including two requiring an additional surgery and one death.No treatment failure was observed after a follow-up of 15.3 months after the end of treatment.Two patients died of non-infectious causes.No specificity could be highlighted in this specific subset of patients.Arterial anastomoses were performed in a termino-terminal fashion using separate stitches of 8-0 or 9-0 non-absorbable sutures (ethilon¿, ethicon inc., scotland, 1915).Reported complications included acute osteomyelitis (n=43), infection(n=48), fever(n=17), local inflammatory symptoms(n=28), pain(n=11), delayed wound healing(n=21), nonunion/sinus tract(n=28), tissue necrosis(n=15), purulent discharge(n=31), abscess(n=22), infection-related death (n=3).In conclusion, osteomyelitis following mandibular reconstruction with ocf represents difficult-to-treat infections with a high risk of treatment failure.Our results advocate for a multidisciplinary management, including an early id specialist referral to manage the antimicrobial therapy driven by complex microbiological documentation, which might include a broadspectrum empirical antimicrobial therapy targeting grampositive and gram-negative bacteria, and anaerobes.

Manufacturer Narrative

Product complaint # (b)(4).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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications/death described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? would the journal author / physician like to speak with ethicon medical safety and engineering via scheduled conference call regarding the product involved in this event? 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.H6 component code: g07002 ¿ device not returned the single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2023-09474.Citation: j.Bone joint infect., 7, 127¿136, 2022 // https://doi.Org/10.5194/jbji-7-127-2022.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18267894
• MDR Text Key: 329738218
• Report Number: 2210968-2023-09473
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention