MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN RIGIDFIX CROSS PIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK RIGIDFIX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: jihoon cha, et al, 2012 ¿analysis of cyclops lesions after different anterior cruciate ligament reconstructions: a comparison of the single bundle and remnant bundle preservation techniques¿, skeletal radiol 41: 997-1002 (south korea).The aim of this study was to compare the prevalence of cyclops lesions after anterior cruciate ligament reconstruction (aclr) using the single-bundle and remnant bundle preservation techniques.One hundred consecutive patients, who had undergone postoperative mri of the knee followed by arthroscopic aclr with the remnant bundle preservation technique (r) between february 2007 and august 2010, were enrolled in this study.Thirty-six consecutive patients who underwent aclr using the single-bundle technique (s) were also included in this study as a control group.The mr findings were scored based on the presence of pre-acl graft lesion as 0, 1, 2, or 3 on the sagittal images.The sixty-one specimens by second-look surgery (20 in s, 41 in r) were pathologically examined.Postoperative mri was performed after arthroscopic acl reconstruction in all the patients.The mean interval between operation and the postoperative mr imaging was 214 days.A second-look operation was performed in 61 patients (20 in group s, 41 in group r).If a cyclops lesion was found, then the lesion was resected and a pathologic examination was requested.The article describes the following surgical procedures: traditional acl reconstruction is done using the single-anteromedial bundle technique and it has a high clinical success rate.However, some studies have shown that 15-25% of patients continue to have pain and instability.The remnant bundle preservation technique consists of minimal debridement of the intercondylar notch and the residual stump of the ruptured acl, which can lead to earlier revascularization and early rehabilitation.However, in the remnant bundle preservation technique, the remnant bundle is located anterior along the acl graft, and so it can mimic a cyclops lesion.Moreover, the residual tibial acl stump can be a source of cyclops lesion.The devices involved were: rigidfix crosspins, interference screw, 23-g wire loop, suture hook.The pre-acl graft lesions were scored on the sagittal proton density images as follows: score 0: normal, score 1: a few strands, score 2: a non-nodular lesion and score 3: a nodular lesion beyond the intercondylar notch line.The three major mr findings of cyclops lesions were (1) soft tissue fullness in the intercondylar notch, (2) intermediate signal intensity material protruding beyond the intercondylar notch line on the sagittal images with a (3) nodular shape and convex anterior border.The numbers of patients with scores of 0, 1, 2, and 3 were 1, 18, 14, and 3 in group s and 4, 60, 29, and 7, in group r, respectively.Of the 61 patients who underwent second-look surgery (20 in s, 41 in r), eight had a cyclops lesion (three in group s and five in group r).Mri findings of cyclops lesions were correlated with the pathologic findings for both techniques.The prevalence of cyclops lesion in the study groups were not significantly different.The mri findings of pathologically proven cyclops lesions will allow radiologists to better diagnose cyclops lesions after single-bundle and remnant bundle preservation acl reconstructions.

• Brand Name: UNKNOWN RIGIDFIX CROSS PIN
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 9145563
• MDR Text Key: 167585452
• Report Number: 1221934-2019-58754
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RIGIDFIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention