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); Pain (1994); Muscle/Tendon Damage (4532); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Title: no difference in long-term outcome between open and arthroscopic rotator cuff repair: a prospective, randomized study this study aims to compare the long-term clinical and imaging outcomes following arthroscopic or open rotator cuff repair.Over a 5-year period (2003-2007), each consecutive patient who underwent unsuccessful conservative treatment for 6 months, who had unaccepted pain and/or weakness caused by a full-thickness tear of the supraspinatus tendon, and who consented to participate in the study was prospectively included.If patients agreed to be part of the study, they were randomized to either open or arthroscopic rotator cuff tear (rct) repair.Randomization resulted in 20 patients per group.The mean age at the time of surgery was 60 years (range, 50-71 years; sd, 6 years) in the arthroscopic surgery group with 12 males and 8 males and 55 years (range, 39-67 years; sd, 8 years) in the open surgery group with 17 males and 3 females.During open rotator cuff tear (rct) repair, the cuff underwent modified repair with 2-4 mason-allen stitches (no.2 fiberwire; arthrex) and transosseous fixation with a cortical bone augmentation device (depuy synthes, raynham, ma, usa).At the end of the procedure, the deltoid muscle was reattached with 2 transosseous stitches (no.2 fiberwire or no.3 ethibond [ethicon, somerville, nj, usa]) and a no.0 running polydioxanone suture (ethicon) to repair the muscle fascia.More than 10 years¿ follow-up was available for 13 patients in the arthroscopic surgery group and 11 patients in the open surgery group, with mean followup periods of 13.8 years (range, 11.9-15.2 years; sd, 1.1 years) and 13.1 years (range, 11.7-15 years; sd, 1.1 years), respectively.Reported complications included: (n=?) higher pain level 1 week after the operation in the open surgery group (6 points).At latest follow-up, (n=1) patient had a disappointing result.(n=10) patients had an irregularity of the acromion, where the osteotomy had been performed.(n=3) capsulitis, of whom required mobilization under interscalene anesthesia and/or a capsulotomy.(n=2) complex regional pain syndrome of the operated limb.A total of (n=6) retear, where (n=1) patient underwent reverse total shoulder arthroplasty [rtsa] implantation because of cuff repair failure, and another (n=1) patient underwent shoulder arthroscopy and re-reconstruction of a retear (supraspinatus); shoulder arthroscopy and acromioclavicular (ac) joint resection.(n=?) osteoarthritis.(n=?) cuff arthropathy.(n=?) increased fatty infiltration within the rotator cuff muscles.It was concluded, that although recent trends for rotator cuff tear (rct) repair favor an arthroscopic technique, neither the arthroscopic nor open surgical procedure, as performed in this study, is superior at 2 years¿ follow-up and probably at >10 years¿ follow-up.Both approaches result in very high patient satisfaction but a retear rate of approximately 30%.The postulated damage to the deltoid caused by deltoid detachment could be refuted for the technique used in this study.

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 2210968-2021-10497.Citation: jses international 4 (2020) 818e825 https://doi.Org/10.1016/j.Jseint.2020.08.0052666-6383/.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6.Health effect - impact code - f07 - patient had an irregularity of the acromion, capsulitis, total retear, cuff arthropathy 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, or its employees that the report constitutes an admission that the product, ethicon, 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.

• 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: 12713582
• MDR Text Key: 284871302
• Report Number: 2210968-2021-10498
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2021
• 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