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 Arthritis (1723); Unspecified Infection (1930); Neuropathy (1983); Seroma (2069); Impaired Healing (2378); Joint Laxity (4526)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #(b)(4).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? 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 2210968-2021-10855.Citation: archives of orthopaedic and trauma surgery (2021) 141:1101¿1108 https://doi.Org/10.1007/s00402-020-03504-5.

Event Description

Title: complications after sternoclavicular surgery the aim of this study was to examine the complications after scj surgery, and especially the incidence of infections.A total of 68 consecutive patients who had a first-time scj surgery in our clinic were included.One of these patients had already had scj surgery in another clinic.The cohort consisted of 22 men and 46 women who had a mean age of 37.5 years (range, 13-70 years).The indication for surgery was osteoarthritis in 27 of 68 patients (39.7%), instability in 37 (54.4%), and other indications in 4 patients (5.9%).In the reconstructive surgery cases, a combination of hamstring tendon with a pds band was mostly used.Primary stabilization of the scj was performed with a hamstring autograft combined with a polydioxanone suture (pds) (ethicon, inc, somerville, nj, usa) in mainly all cases.This technique was also executed in the case of an mcr.An anterior transverse incision was made across the medial aspect of the clavicle to the manubrium.The medial aspect of the clavicle was subperiosteally exposed and the scj was identified.A small incision was made in the capsule, providing room for inspection of the cartilaginous disc.Osteophytes, calcifications, and scar tissue were removed.Four 4-mm-diameter v-shaped drill holes were made, 2 in the manubrium and 2 at the medial end of the clavicle, spaced 1 cm apart.First, the previously harvested tendon was passed through the inner drill holes of the clavicle, crossing the joint, and passed through the hole in the manubrium.Then, the ligament was crossed back, in a figure-of-8 form, through the same hole in the clavicle, then brought under manual tension, and the endings were sutured to each other with a pds- 0 wire.In the same manner, a pds band was passed through the outer drill holes and sutured with the pds-0 wire to each other in the center.After closure of the capsule and closing of the overlying muscle, the wound was closed using a 4-0 monocryl skin suture (ethicon, inc.).Of the 68 scj surgeries that were performed, an infection occurred in 16 patients (23.5%).Eight of these occurred within 6 weeks after surgeryd11.8% of the whole cohort.Complications such as wound healing problems and scar tissue problems were seen in 5 cases at the scj surgical site, of which 1 underwent a needle drainage of a seroma and 3 at the donor site.One of the latter resulted in saphenous nerve neuropathy due to a seroma.Two frozen shoulders were seen.A total of 26 reoperations (14 due to clinical signs of infection, 9 due to instability, 1 due to osteoarthritis,2 due to other causes) were performed in our cohort.Seven of the infected cases needed multiple surgeries to eradicate the pathogen and achieve an acceptable clinical situation.Five of these 7 needed revision of fixation after treatment for infection.One scj remained unstable, even after revision surgery.Postoperative complications included n=16 infections, n=5 wound healing problems and scar tissue problems at the scj surgical site, n=1 osteoarthritis and n=9 recurrent instability.In conclusion, complications after scj surgery occur more often than previously described.C.Acnes infections are often seen.When left untreated, these complications can lead to persistent complaints or recurrent instability due to failure of reconstruction.Therefore, it is of utmost importance to identify infections at an early stage, or better, to prevent them.The use of benzoyl peroxide gel preoperatively seems effective in reducing early c.Acnes infections in this type of surgery.

• 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
• MDR Report Key: 12749008
• MDR Text Key: 285414611
• Report Number: 2210968-2021-10853
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• 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: 10/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention