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 Pain (1994); Loss of Range of Motion (2032)

Event Date 04/19/2021

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.Citation: knee surgery, sports traumatology, arthroscopy https://doi.Org/10.1007/s00167-021-06576-x.

Event Description

Title: posterior knee arthroscopy facilitates the safe and effective all-inside repair of locked bucket-handle medial meniscal tear using a suture hook technique this study aims to describe the clinical outcomes and technical aspects of using the arthroscopic posterior approach for the arthroscopic repair of locked bucket-handle medial meniscal tears (bhmmts) during anterior cruciate ligament (acl) reconstruction.Between 2011 and 2014, 48 knees underwent arthroscopic repair for locked bucket-handle medial meniscal tears (bhmmts) during anterior cruciate ligament (acl) reconstruction.Eleven females and 37 males with locked bucket-handle medial meniscal tears (bhmmts) who met the inclusion criteria were enrolled in the study.The mean age at the time of operation was 27 ± 6.8 years.The mean bmi was 24.6 ± 2.1 kg/m2.The mean interval between anterior cruciate ligament (acl) tear and surgery was 23.7 ± 6.8 months.In 27 patients with tear extension to anterior third, an outside-in technique with a no.1 pds (polydioxanone) was used.During surgery, posterior meniscal borders and the adjacent synovium were abraded with a shaver up to the posterior corner point.A loaded suture hook (lasso conmed-linvatec, utica, ny, usa) with a no.1 pds (polydioxanone) (ethicon; somerville, nj, usa) was passed through the peripheral and central segment of the medial meniscus via the posteromedial portal following the all-inside method.For patients with tears extending to the anterior third, the outside-in technique was performed with a no.1 pds (polydioxanone) , starting just anterior to the medial collateral ligament (mcl).The last follow-up took place 39¿53 months after surgery (46.7 ± 7.1 months, mean ± sd).Reported complications included: (n=2) patients suffered from some pain.(n=2) patients could not exhibit full knee flexion, though no recurrence of locking was reported.None of the patients underwent reoperation or suffered any new injuries that required treatment.It was concluded, that using posterolateral (transseptal) and posteromedial portals can provide surgeons with an excellent view of the posteromedial compartment.This study showed favorable clinical results after this technique was used to repair locked bucket-handle medial meniscal tears (bhmmts) during anterior cruciate ligament (acl) reconstruction.

• 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: 12711249
• MDR Text Key: 284458843
• Report Number: 2210968-2021-10486
• 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: 10/14/2021

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
• Date Manufacturer Received: 10/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention