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 Problem Muscular Rigidity (1968)

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).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.Attempts are being made to clarify 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 ethicon products (pds ii suture, ethibond suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (pds ii suture, ethibond suture) used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number patient demographics the single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: archives of orthopaedic and trauma surgery (2020) 140:67¿76; doi: https://doi.Org/10.1007/s00402-019-03285-6.(b)(4).

Event Description

Title:trans-tendon suture bridge rotator cuff repair with tenotomized pathologic biceps tendon augmentation in high-grade pasta lesions the purpose of this retrospective study was to evaluate whether trans-tendon suture bridge repair with tenotomized pathologic biceps tendon augmentation improves mid-term clinical outcomes for high-grade partial articular-sided supraspinatus tendon avulsion (pasta) lesions or not.Between march 2010 and november 2016, 115 patients (male=44, female=71; mean age= 59.7 ± 7.6 years, age range=38 ¿ 77 years) underwent arthroscopic trans-tendon suture bridge repair with biceps tendon augmentation for high-grade pasta lesions.During the procedure, a suture marker was placed in the center if the cuff defect to locate the corresponding bursal-sided rotator cuff.A spinal needle was used to pass a no.1 polydioxanone (pds suture; ethicon) as the suture marker.The arthroscope was then moved to the subacromial space where the four strands were tied, and an additional suture in the form of no.2.0 ethibond (ethicon) was used to repair and compress the pasta lesion in the subacromial space.Reported complications included shoulder stiffness (n=5) in which 4 were treated with a subacromial corticosteroid injection at 3 months postoperatively and subsequently showed improved range of motion (rom) requiring no further treatment.One remaining patient showed persistent stiffness even after two corticosteroid injections at 3 and 6 months postoperatively and subsequently underwent arthroscopic capsular release that resulted in a good functional outcome; full thickness tear (n=2) which were treated conservatively including physiotherapy with nearly full thickness rotator cuff retears.In conclusion, high-grade pasta lesions, arthroscopic trans-tendon suture bridge repair with tenotomized pathologic biceps tendon augmentation could be useful treatment modality capable of preserving rotator cuff footprint providing simultaneous biceps tenodesis, including sufficient thickness tendon healing and preventing residual pain of the conventional tran-tendon repair methods.These specific methods showed satisfactory clinical outcomes and decreased residual shoulder discomfort at mid-term follow-up.".

Manufacturer Narrative

Additional information was requested, and the following was obtained: have no idea about any complications of the ethicon.Reply of your questions--nothing.Does the surgeon believe that ethicon products (pds ii suture, ethibond suture) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (pds ii suture, ethibond suture) used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9988929
• MDR Text Key: 191584950
• Report Number: 2210968-2020-03387
• 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,Followup
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• 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: 04/30/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention