MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Therapeutic Response, Decreased (2271); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(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.Citation: j trauma.2011; 72(2).Doi: 10.1097/ta.0b013e3182319d5a.[(b)(4)].

Event Description

It was reported via journal article title: "clinical outcome of arthroscopic fixation of anterior tibial eminence avulsion fractures in skeletally mature patients: a comparison of suture and screw fixation technique".Authors: ru-yu pan, md, jui-jung yang, md, jen-huei chang, md, hsain-chung shen, md, leou-chyr lin, md, and yu-tung lian, rn,.Citation: j trauma.2011; 72(2).Doi: 10.1097/ta.0b013e3182319d5a.Extreme tensile force to the anterior cruciate ligament results in an avulsion of the tibial eminence and it was believed to be more common in skeletally immature adolescent than adult.The purpose of this study was to compare the clinical results of both screw and suture fixation for surgical treatment of anterior tibial eminence fractures in skeletally mature patients.A retrospective review was conducted on patients from 2002 to 2009 who sustained fractures of the anterior tibial eminence and were treated with arthroscopic-assisted fixation using either cannulated screws (25 patients; 14 male and 11 female patients; age range: 18 to 52 years old) or ethibond sutures (23 patients; 16 male and 7 female patients; age range: 17 to 50 years oldl).In the suture fixation group, a polydioxanone 2-0 (ethicon) was used as a suture guide by passing it through the knee joint via the anteromedial portal, followed by the medial loop, the posterior part of the acl, and the lateral loop.The second guide suture was then passed through the medial loop, the anterior part of the acl, and the lateral loop.The suture retrievers were pulled out to shuttle the polydioxanone suture through the medial and lateral bone tunnel.The four strains of ethibond 5-0 sutures (ethicon) were then tied over the proximal tibia.In the suture fixation group, reported complications included joint stiffness (n-1), symptomatic giving away sensation (n-2) which required acl reconstruction (n-1), grade 1 pivot shift (n-5), grade 2 pivot shift (n-3), grade 3 pivot shift (n-1), extension deficit (n-6), and flexion deficit (n-5).Most fractures of the anterior tibial eminence in skeletally mature patients resulted from traffic-related injuries in this study.Significant better ikdc objective form, lower glide pivot shift phenomenon, and shorter operating time requirement in screw fixation group with respect to suture fixation group were shown in the study.

• 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 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7810628
• MDR Text Key: 118091570
• Report Number: 2210968-2018-75363
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 08/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• 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: 08/07/2018
• 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