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 Joint Dislocation (2374); Not Applicable (3189)

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.To date no response has been provided.If further details are received at a 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 (pds ii 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 (pds ii suture) used in this procedure? citation: the orthopedic journal of sports medicine; 4(6).2325967116654114.Doi: 10.1177/2325967116654114.(b)(4).

Event Description

It was reported via a journal article"title: comparison of time to recurrence of instability after open and arthroscopic bankart repair techniques." authors: mandeep s.Virk, md; richard l.Manzo, md; mark cote, dpt; james k.Ware, md; augustus d.Mazzocca, md; carl w.Nissen, md; kevin p.Shea, md; robert a.Arciero, md.Citation: the orthopedic journal of sports medicine; 4(6).2325967116654114.Doi: 10.1177/2325967116654114.The purpose of the study was to compare the time to recurrence (ttr) of instability and disease-specific outcome measures in patients undergoing open and arthroscopic bankart repair.Patients with recurrent traumatic anterior shoulder instability and a bankart lesion on diagnostic arthroscopy underwent either open bankart repair (ob; 24 patients; age range: 20.3 to 27.5 years; 1 female and 23 male patients) or arthroscopic bankart and suture capsulorrhaphy (absc; 58 patients; age range: 22.3 to 27.2 years; 13 female and 45 male patients) using suture anchors.During the surgical procedure in the arthroscopic technique, after elevating the scarred labrum and preparing the glenoid rim to reveal bleeding subchondral bone, pds 0 sutures (ethicon) was used to place the shuttling suture through the labrum with the use of the spectrum suture passer.The first passing suture was brought through the redundant capsule in a location inferior to the first intended anchor location (usually at 6 o'clock).The rotator interval was closed with a pds 0 sutures (ethicon).In the arthroscopic technique group, reported complications included patient 3, an (b)(6)-year-old patient with subluxation; patient 4, a (b)(6)-year-old patient with dislocation; patient 5, a (b)(6)-year-old patient with subluxation; patient 7, a (b)(6)-year-old patient with subluxation; patient 8, a (b)(6)-year-old patient with subluxation; patient 9, a (b)(6)-year-old patient with subluxation; patient 11, a (b)(6)-year-old patient with dislocation.It was reported that 4 of the 7 failures underwent revision surgery and 3 patients with recurrent subluxation refused surgery.This retrospective study demonstrates that the time of recurrence of instability is significantly shorter with arthroscopic bankart repair compared with the open bankart repeur technique.However, the recurrence of instability (dislocation and symptomatic subluxation) and instability-specific outcome measures (wosi scores) were not significantly different between the open and arthroscopic bankart repair techniques.

• 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
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9521427
• MDR Text Key: 189032436
• Report Number: 2210968-2019-91324
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• 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: 12/04/2019
• 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
• Patient Age: 17 YR