MAUDE Adverse Event Report: ETHICON INC. ETHIPIN UNKNOWN; SUTURE, SURGICAL, ABSORBABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Damage to Ligament(s) (1952); Joint Dislocation (2374)

Event Date 01/01/2021

Event Type  Injury  

Event Description

Title: refixation of large osteochondral fractures after patella dislocation shows better mid- to long-term outcome compared with debridement.The purpose of this study was to compare results of osteochondral fractures after first-time lateral patella dislocation, when either refixation or debridement was performed in a mid- to long-term follow-up and to analyze redislocation and reintervention rates.Between 2006 and 2016, 53 patients who underwent subsequent surgical intervention within the first week after dislocation with either refixation of osteochondral fractures or debridement of defect site were included in the study.There were 29 males and 24 females with a mean age of 19.5+/- 5.5 years (range 12.8 -31.5 years).Refixation was performed in 28 patients while 25 patients underwent removal and debridement.For refixation of fragments, bioabsorbable pins with 1.3 mm diameter and customized length (ethipins 1.3 mm, ethicon) consisting of poly-p-dioxanon (pds) were used.Depending on the size of each fragment, 1 to 6 pins per patient were implanted.If crushed fragments were obtained and refixation was not possible due to severity of damage or complete absence of subchondral bone, the defect site underwent arthroscopic debridement with complete opening of subchondral bone with a curette or a shaver to induce fibrocartilage formation.All patients were mobilized with partial weightbearing from the next day to 6 weeks.All patients received continuous passive motion therapy until full weightbearing.Mean follow-up was 8.9 years (±4.4, range 2.0- 16.7 years).The reported complications included symptomatic cartilage defects (n=2) and redislocation (n=10).In conclusion, refixation of osteochondral fractures after lateral patella dislocation shows improved clinical outcome at mid- to long-term follow-up compared with debridement.Therefore, effort to try fragment refixation is recommended.Redislocation rate is high without proper restoration of patellofemoral instability.

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: cartilage 2021, vol.13(suppl 1) 966s¿973s, https://doi.Org/10.1177/1947603519886637.

• Brand Name: ETHIPIN UNKNOWN
• 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: 15887967
• MDR Text Key: 304550586
• Report Number: 2210968-2022-09852
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• 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: 11/15/2022
• 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