MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXCEL SUTURE 36"(90CM) 0 WHT; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	PX65H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethibond x865, vicryl plus vcp616, vicryl plus vcpb269 or monocryl, plus mcp316 suture used in this procedure? citation: journal of arthroplasty 2014;29(2):283-287.Http://dx.Doi.Org/10.1016/j.Arth.2013.05.031.- (b)(4).
Event or Problem Description
It was reported in journal article ¿barbed versus traditional sutures: closure time, cost, and wound related outcomes in total joint arthroplasty¿ that purpose of the study was to prospectively investigate barbed sutures by comparing them to traditional sutures.The patient underwent total joint arthroplasty on unknown date between (b)(6) 2010 and suture was used distal interrupted and proximal running on the fascia.Post-operatively the patient may have experienced prominent suture treated with removal with forceps and application of antibiotic ointment.The patient possibly experienced superficial infection successfully treated with oral antibiotics.In conclusion, barbed sutures are associated with a decreased time to wound closure following tka's and tha's and the financial benefit associated with saving time in the operating room is significant.Additional information has been requested.

• Brand Name: ETHIBOND EXCEL SUTURE 36"(90CM) 0 WHT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7213324
• Report Number: 2210968-2018-70417
• Device Sequence Number: 1169351
• Product Code: GAT
• UDI-Device Identifier: 10705031049246
• UDI-Public: 10705031049246
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: PX65H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention