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 Erythema (1840); Pain (1994); Post Operative Wound Infection (2446)

Event Date 02/08/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2021-08026, and 2210968-2021-08027.Citation: https://doi.Org/10.1016/j.Injury.2020.02.011.

Event Description

Title: olecranon mayo iia fractures treated with transosseous high strength suture: a series of 29 cases.This prospective study aims to evaluate the complications of transosseous suture technique and compare them with the traditional tension band wiring.A total of 29 patients managed with transosseous suture technique between 2010 and 2018 were included.The selection criteria included patients over 40 years of age, without maximum age limit, whose fracture was classified as mayo iia.The high strength threads used were ethibond no.5 (ethicon, somerville, nj), in 55,2% of cases or ultrabraid no.2 (smith & nephew, andover, ma) in 37,9%).In all cases intraoperative x-ray imaging was used, as well as the ischemia cuff.Closure of soft tissues was carried out with vicryl 2¿0 (vicryl 2, pds ii; ethicon, johnson & johnson, somerville, ny), and closure of skin was performed with staples (except the patient affected of multiple chemical sensitivity, which skin closure was performed with non-absorbable monofilament).X-rays were taken after 2 weeks, 6 weeks and 6 months, recording complications, causes, rates of re-operation and the final clinical condition.Median time for ischemia and surgery were 51 (95% ci:48;62) and 45 (95% ci:42;55) minutes respectively.It has been observed that 24,1% (7 cases) present diastasis of the posterior cortex at the fracture site (maximum 3,1 mm) without causing a clinically altered joint range of motion.There was only one case of aseptic non-union.Among these cases, three patients (10,3%) suffered wound infection.One of them (3,4%) presented as pain and erythema, without exudate.The patient was treated with oral 875/125 mg amoxicillin/clavulanic acid for ten days, with resolution of the superficial infection.Nevertheless, two of the three patients (6,8%) required antibiotic and surgical debridement.Osteosynthesis removal was not necessary in any case.Post-operative evolution was satisfactory, preserving good functionality, and full mobility after 6 months.Reported postoperative complications included n=7 diastasis of the posterior cortex at the fracture site, n=1 aseptic non-union, n=3 wound infection, n=1 pain and erythema.In conclusion, transosseous suture with high strength thread can be a valid alternative for treating mayo iia olecranon fractures in adult patients even with osteoporotic bone.In addition, preliminary results suggest that this type of technique can reduce the rate of re-operation to remove material.It may also be the treatment of choice in patients who cannot be operated by conventional 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
• MDR Report Key: 12422222
• MDR Text Key: 270323481
• Report Number: 2210968-2021-08028
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• 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: 08/20/2021
• 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