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 Contracture (4528); Insufficient Information (4580)

Event Date 11/16/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.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? which specific ethicon products have been used during the procedures (product code, lot number)? 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: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events submitted via 2210968-2023-01348.Citation cite: front.Bioeng.Biotechnol.10:1055176.Https://doi.Org/10.3389/fbioe.2022.1055176.

Event Description

Title: the safety, efficacy, and functional outcomes on arthroscopic fixation of posterior cruciate ligament avulsion fracture by a bio-absorbable anchor or traditional pull-out technique: a prospective (b)(4) study.This study aims to estimate and compare the safety, efficacy, and functional outcomes between the bio-absorbable anchor and the traditional suture pull-out technique for arthroscopic fixation of pclaf.This was a prospective (b)(4) study.Pclaf patients were included from 1 january 2020, to 31 august 2021, randomly divided into the absorbable anchor group and control group (pull-out suture fixation).31 patients had accomplished the 1 year follow-up.No.2 ethibond suture, pds johnson & johnson were used.Reported complications included total failure rate : a-p laxity of grade 2¿3 (n=3), knee flexion contracture (kfc) grade 1 ( n=1), knee flexion limitation (kfl) grade 3 (n=1) in conclusion both the bio-absorbable anchor and suture pull-out technique for arthroscopic fixation of pclaf have acquired a well bone union and superior safety, but the bio-absorbable anchor group had better efficacy and functional outcomes than the traditional pull-out technique.

• 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: 16442966
• MDR Text Key: 310241238
• Report Number: 2210968-2023-01349
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• 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: 02/17/2023
• 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): Other