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

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

Patient Problems Unspecified Infection (1930); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article.The device was not returned, therefore an analysis investigation could not be performed.The lot/batch was not provided, therefore the manufacturing records could not be reviewed.

Event Description

It was reported in a journal article entitled: augmented compared with non-augmented surgical repair of a fresh total achilles tendon rupture authors: ari pajala, md, jarmo kangas, md, pertti siira, pht, pasi ohtonen, msc, and juhana leppilahti, md, phd citation: j bone joint surg am.2009; 91: 1092 100.Doi: 10.2106/jbjs.G.01089 augmented and non-augmented techniques have been used for the operative repair of a fresh complete achilles tendon rupture.Augmented techniques have been favored for their stronger pull-out strengths but have been avoided because of the risk of wound complications.The authors hypothesized that augmentation with a down-turned gastrocnemius fascia flap would not provide better results than would end-to-end suture repair with use of the krackow locking loop surgical technique.A total of 60 patients with an acute achilles tendon rupture were randomized to receive end-to-end suture repair with use of the krackow locking loop technique either without augmentation (simple repair group; 32 patients) or repair by means of augmentation with a down-turned gastrocnemius fascia flap (augmented repair group; 28 patients).During the surgical procedure in both groups, irregular tendon ends were cleaned and repaired with the krackow technique as described with use of two separate pds 0 sutures and vicryl 2-0 sutures.In the simple repair group, no augmentation was used whereas in the augmented repair group, a 10-mm-wide central gastrocnemius aponeurosis flap was turned down over the rupture repair and was sutured to the distal part of the achilles tendon with vicryl 2-0 sutures.In all cases after repair, the fascia was carefully re-sutured with vicryl, and the skin was closed with ethilon sutures.It was reported that a (b)(6) man in the augmented repair group had a deep infection.He had development of clear drainage from the incision at three weeks.He immediately underwent wound debridement, and the ´ wound was left open.Cultures of specimens from the wound were negative.After the patient had received seven days of treatment with intravenous antibiotics, we were able to close the wound with a two-tailed cutaneous turnover flap, and it healed without further evidence of infection.The patient was able to walk normally at the time of the one-year follow-up.

• Brand Name: ETHILON NYLON SUTURE
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7426273
• MDR Text Key: 105372558
• Report Number: 2210968-2018-72108
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2018
• 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
• Patient Age: 36 YR