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 Muscular Rigidity (1968); Pain (1994)

Event Date 06/05/2022

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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: journal of shoulder and elbow surgery (2022), doi: https://doi.Org/10.1016/j.Jse.2022.06.001.

Event Description

Title: arthroscopic lateral collateral ligament imbrication of the elbow: short-term clinical results the purpose of this retrospective study is to show the validity of a modified arthroscopic technique.A total of 20 patients (8 male and 12 female; mean age was 40.1 (range 20-61, sd 14) years) with posterolateral rotatory instability (plri) that underwent arthroscopic lateral collateral ligament (lcl) imbrication from 2010-2013 were included.Surgery was performed using pds ii sutures (ethicon, j&j medical, usa).The mean (sd) follow-up was 25.3 (2.3) months.Reported complications include continuing pain with persistent posterolateral rotatory instability clinically (lateral pain, with all three plri tests positive) at 7 months¿ follow-up (n=1) requiring a formal lucl reconstruction was performed, with persistent lateral pain thereafter.Elbow stiffness four months postoperatively (n=1) and was successfully treated by manipulation under anesthesia.Tenderness of the subcutaneous pds knots (n=2) which resolved spontaneously within three months.In conclusion, as a less invasive alternative to open lcl reconstruction using a graft, arthroscopic lcl imbrication has demonstrated acceptable rates of perceived elbow stability among patients with stage 1 or 2 plri.

• 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: 15681692
• MDR Text Key: 302505331
• Report Number: 2210968-2022-08847
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• 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: 10/13/2022
• 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