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 Problems Local Reaction (2035); Post Operative Wound Infection (2446)

Event Date 11/26/2021

Event Type  Injury  

Event Description

Title: clinical and functional outcome of surgery for posttraumatic cloacal deformity authors: arcangelo picciariello1 | gaetano gallo2 | alessandro sturiale3 | francesco litta4 | veronica de simone4 | gennaro martines1 | gabriele naldini3 | carlo ratto4 | mario trompetto5 | marcella rinaldi1 citation: colorectal disease.2021;00:1¿7.Doi: 10.1111/codi.16008.The aim of this multicentre retrospective study is to assess the clinical and functional outcome of patients treated for traumatic cloacal deformity using three different surgical techniques.A total of 38 women (with a median age of 34 years [interquartile range (iqr) 31¿39 years]) operated on for fourth-degree cloacal deformity between january 2015 and january 2019 were included in the study.After the anoplasty, perineoplasty was performed in 3 different techniques.In 23 patients, direct suture of the rectovaginal septum was performed by: an end-to-end or overlapping sphincteroplasty is carried out using separate nonabsorbable (pds 3/0) stitches and the reconstruction is completed with longitudinal midline closure of the perineal skin by interrupted sutures (unknown) (figure 1a).In 10 patients, singapore flap technique was performed by: the flap is lifted up by the upper part, left-rotated by 90° and fixed (interrupted vicryl® 3/0) in order to cover the repaired external sphincter (figure 1b).In 5 patients, the x-flap technique was performed by: the posterior wall of the vagina and the anterior wall of the anal canal are then reconstructed by two 2/0 polyglactin sutures each (vicryl®, ethicon inc.); subsequently, an overlapping or end-to-end sphincteroplasty is performed; the anterior perineal plane is then reconstructed from transverse muscles of the perineum; the flaps are then transposed beyond the midline and sutured by poliglecaprone sutures (monocryl®, ethicon inc.; figure 1c).A diverting stoma was performed in 3 patients after x-flap perineoplasty and in 14 treated by direct closure.Reported complications include surgical wound infection classified as clavien-dindo ii (n=2) in the singapore flap group and clavien-dindo iii (n=1) in the direct closure group which require a second-look surgery in the patients in the direct closure group; and wound problems with no infection (n=14) nine patients with the direct closure, two patients with the x-flap and three patients in the singapore flap group.In conclusion, regardless of the technique used, surgical repair significantly improves both clinical and functional outcomes irrespective of the presence of a covering stoma.Nevertheless, even if in this relatively large series there was no difference in term of complication rate, the need to perform a protective diverting stoma should be better addressed by a randomized clinical trial.

Manufacturer Narrative

Product complaint # (b)(4).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 any of the 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 any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-03863.Citation: colorectal disease.2021;00:1¿7.Https://doi.Org/10.1111/codi.16008.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14435549
• MDR Text Key: 292032132
• Report Number: 2210968-2022-03864
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2022

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/19/2022
• 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
• Patient Sex: Female