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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 01/01/2017

Event Type  Injury  

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 there was any deficiency with the ethicon suture used in this procedure led to the complications reported? citation: eur j plast surg (2009) 32:19¿22.Doi 10.1007/s00238-008-0300-9.

Event Description

It was reported in journal article ¿the use of vicryl¿ in extensor tendon repairs¿ the authors investigated the use of suture for the treatment of extensor tendon repairs and compare its use with other nonabsorable suture materials.A retrospective case study of patients who underwent acute extensor tendon repairs of the hand between january and june 2006 was performed.Repairs were classified by the type of suture material used.A comparison of suture materials was made in terms of rupture rate as well as joint stiffness.During the period, tendon rupture was reported and was associated with wound infection.Additional information has been requested.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7118441
• MDR Text Key: 94890230
• Report Number: 2210968-2017-71790
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2017
• 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): Required Intervention