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 Granuloma (1876); Pain (1994)

Event Date 05/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Component code: (b)(4) device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-05180, 2210968-2022-05181, 2210968-2022-05182, 2210968-2022-05183, 2210968-2022-05184, 2210968-2022-05185.2210968-2022-05186, 2210968-2022-05187, 2210968-2022-05188.Citation: https://doi.Org/10.1007/s00192-021-04822-x.

Event Description

Title: early secondary repair of obstetric anal sphincter injuries (oasis): experience and a review of the literature.This study aims to perform a narrative review of the literature regarding early secondary repair of obstetric anal sphincter injuries (oasis) following wound dehiscence.Second, it retrospectively aims to demonstrate the authors experience in the management of dehisced primary obstetric anal sphincter injuries (oasis) repair with reference to wound healing outcomes, anorectal symptoms and sphincter integrity, comparing these outcomes to a control group of primary repairs without wound breakdown.Between july 2010 to october 2019, an analysis of all women who underwent early secondary obstetric anal sphincter injury (oasi) repair or primary repair alone at (b)(4) university hospital was performed.510 patients underwent primary repair of oasis and were subsequently seen 3 months postpartum in our perineal clinic.Six of these women experienced dehiscence of their primary repair and underwent early secondary repair.During secondary wound closure, the wound was irrigated with a 50:50 dilution of 3% hydrogen peroxide and 0.9% sodium chloride.Wound debridement was then completed.If the anal epithelium had broken down, it was repaired separately with a continuous, non-locking 3¿0 vicryl (polyglactin) suture.Perineal repair was completed in three layers using 2¿0 vicryl rapide (polyglactin) suture material.If the internal anal sphincter (ias) repair was broken down, it was repaired separately by end-to-end approximation using horizontal mattress sutures.If the full length of the external anal sphincter (eas) was identified it was repaired using an overlap technique.Reconstruction of the external anal sphincter (eas) with overlap repair using 3¿0 pds (polydioxanone) dyed sutures.If this was not possible, an end-to-end repair was performed similar to the technique of internal sphincter repair.Reported complications included: complications following secondary suturing:patient 1, 32-year-old, underwent overlap external anal sphincter (eas) repair technique had hematoma- granulation tissue sinus.External anal sphincter (eas) proximal 3-h partial thickness defect and 3-h partial thickness defect distal.Developed asymptomatic perineal sinus tracts.Granulation tissue formation required cauterization with silver nitrate and hematoma formation, was managed conservatively with antibiotic prophylaxis.For developed asymptomatic perineal sinus tracts, was confirmed to be blind-ending and was laid open, with no further surgical intervention required.Patient 2, 19-year-old,underwent end to end internal anal sphincter (ais) and external anal sphincter (eas) repair technique, had granulation tissue fistula.Residual of internal anal sphincter (ais) 2-h defct.External anal sphincter (eas) proximal 2-h partial thickness defect and 2-h partial thickness defect distal.Developed asymptomatic perineal sinus tracts.Granulation tissue formation required cauterization with silver nitrate.For asymptomatic perineal sinus tracts, was found to be complex in nature and shown to communicate with the anal canal on magnetic resonance imaging.However, this patient was lost to follow-up.Patient 3, 28-year-old, underwent end to end external anal sphincter (eas) repair technique,had skin dehiscence.Residual of internal anal sphincter (ais) 4-h defect.Managed expectantly (healing by secondary intention).Patient 4, 43-year-old, underwent end to end external anal sphincter (eas) repair technique, had skin dehiscence granulation tissue with anorectal symptoms of fecal urgency.Managed expectantly (healing by secondary intention).Granulation tissue formation required cauterization with silver nitrate.Intervention for fecal urgency was not reported.Patient 5, 29-year-old, underwent end to end external anal sphincter (eas) repair technique had skin dehiscence with anorectal symptoms of flatal incontinence and fecal urgency.Residual of internal anal sphincter (ais) 4-h defect.External anal sphincter (eas) 2-h partial thickness defect.Managed expectantly (healing by secondary intention).Patient 6, 25-year-old, underwent overlap external anal sphincter (eas) and end to end internal anal sphincter (ias) repair technique had granulation tissue dyspareunia.Granulation tissue formation required cauterization with silver nitrate.It was concluded , that this early secondary repair is a feasible surgical procedure for the reconstruction of dehisced obstetric anal sphincter injuries (oasis).This case series and review of the literature can be used by clinicians to understand management options and counsel women presenting with wound dehiscence following primary obstetric anal sphincter injury (oasi) repair.

• 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 ; 9083863534
• MDR Report Key: 14945293
• MDR Text Key: 295419020
• Report Number: 2210968-2022-05189
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• 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: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 25 YR
• Patient Sex: Female