MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problem Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Attempts are being made to obtain the following information.If further details are received at the 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 (ethibond or pds suture) 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 (ethibond or pds suture) used in this procedure? citation: ir med j.2017 may 10;110(5):566.(b)(4).

Event Description

It was reported via journal article "title: absorbable polydioxanone (pds) suture provides fewer wound complications than polyester (ethibond) suture in acute tendo-achilles rupture repair." authors: m n baig, j g galbraith, i yousaf, robert din.Citation: ir med j.2017 may 10;110(5):566.This prospective study aimed to compare the outcomes including infection rate and boyden score between the two groups repaired by polydiaxonone and polyester in patient with acute achilles rupture.A total of 53 patients (n=35 male and n=18 female; aged 20-75 years) with acute achilles rupture underwent repair using 1 pds (n=34) and 5 ethibond sutures (n=19).Complications included superficial wound infection (n=2 ethibond group) treated with oral antibiotics, deep wound infection (n=4 ethibond group) treated with course of intravenous antibiotic treatment and additional reoperation for debridement and reclosure in one patient, and deep vein thrombosis (n=1 pds group).Generally, the presence of suture material in a surgical wound is known to cause adverse effects on the local tissue condition and increases the susceptibility to infection.Surgical sutures potentiate infection when necrotic or devascularized tissue, haematoma or dead space is caused by tissue damage or when poor surgical technique is used.The surgical repair with monofilament non-braided absorbable suture polydioxanone (pds) is superior to ethibond as it results in significantly lower post-op wound complications and higher patient boyden scores.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8387504
• MDR Text Key: 137731855
• Report Number: 2210968-2019-79233
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• 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: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention