MAUDE Adverse Event Report: ETHICON INC. ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN; SUTURE, NONABSORBABLE, SYNTHETIC

Health Effect - Clinical Codes	Foreign Body Reaction (1868); Unspecified Infection (1930); Not Applicable (3189)
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.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 ethicon products used in this procedure? citation: foot and ankle international® 2015, vol.36(6) 691¿695; doi: 10.1177/1071100714568868.(b)(4).
Event or Problem Description
It was reported via journal article: "title : evaluation of absorbable and nonabsorbable sutures for repair of achilles tendon rupture with a suture-guiding device" author: baris kocaoglu, md, tekin kerem ulku, md, arel gereli, md, mustafa karahan, md, and metin turkmen, md citation: foot & ankle international® 2015, vol.36(6) 691¿695; doi: 10.1177/1071100714568868.The purpose of this randomized blind study was to compare the functional and clinical results of achilles tendon repair with an achilles tendon suture-guiding device using nonabsorbable versus absorbable sutures.From jan2010 to sep2013, 48 patients (average age of 38 years [ranged 28-50 years]) with sustained a spontaneous acute rupture of the achilles tendon underwent operative repair with an achilles tendon suture-guiding device using 2 different suture types.In the nonabsorbable suture group, no.2 ethibond suture was used, and in the absorbable suture group, vicryl suture was used.In both groups, the paratenon was closed using 2/0 monocryl sutures and the skin was closed with subcuticular 4/0 monocryl sutures.Postoperatively in nonabsorbable suture group, complications included deep infection (n=1) which was treated without any residual deficit by debridement and parenteral antibiotic therapy, and foreign body reaction (n=2).The first patient complaint of swollen achilles tendon and pain when walking six months after surgery for which pathologic examination showed inflammatory tissue surrounding the ethibond suture.This patient underwent exploration and revision surgery with excision of the macroscopically abnormal tendon, and patient was comfortable with no signs of infection 6 months post revision.The other patient developed superficial erythema at 3 weeks post-op managed with antibiotics, but had recurrent episodes over the next two months requiring antibiotics.Moreover, the patient presented fluid collection on the lateral side of the ankle at 6 months which was drained and the wound was explored and debrided.Foreign body reaction was observed around the ethibond suture knot which was removed.The patient wound fully healed with no further problems and had a fully functional tendon and resumed his normal activities of daily living.Use of an absorbable suture in the treatment of achilles tendon repair by an achilles tendon suture guiding system was associated with a lower incidence of suture reaction; however, functionally the results were not notably different from those using a traditional nonabsorbable suture.We conclude that repair with absorbable sutures is appropriate for achilles tendon ruptures.

• Brand Name: ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7770155
• Report Number: 2210968-2018-75052
• Device Sequence Number: 18170775
• Product Code: GAT
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2018

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 08/09/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention