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.Concomitant medical products: unknown.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 is report 1 of 2 for the same event.This report is being filed after the review of the following journal article: inacio, am., et al.(2014) "reconstruction of the anterior cruciate ligament by means of an anteromedial portal and femoral fixation using rigidfix", vol.49, no.6, pages 619-624 (brazil).This study emphasizes on evaluating a series of patients who underwent surgery for reconstruction of the anterior cruciate ligament with flexor tendons, by means of the anteromedial transportal technique using rigidfix for femoral fixation, and to analyze the positioning of the pins by means of tomography.The patients evaluated on course of this study: thirty-two patients were included in the study.All of them were operated by the same surgical team between january 2009 and july 2010.The clinical evaluation was done using the lysholm, subjective ikdc and rolimeter.All of them underwent computed tomography with 3d reconstruction in order to evaluate the entry point and positioning of the rigidfix pins in relation to the joint cartilage of the lateral condyle of the femur.The mean lysholm score obtained was 87.81 and the subjective ikdc was 83.72.Among the 32 patients evaluated, 43% returned to activities that were considered to be very vigorous, 9% vigorous, 37.5% moderate and 12.5% light.In 16 patients (50%), the distal entry point of the rigidfix pin was located outside of the cartilage (extracartilage); in seven (21.87%), the distal pin injured the joint cartilage (intracartilage); and in nine (28.12%), it was at the border of the lateral condyle of the femur.The article describes the following procedure: anterior cruciate ligament (acl) reconstruction surgery.The devices involved were: rigidfix for femoral fixation and biointrafix (mitek, norwood, ma, usa) for tibial fixation.Complications mentioned in the article were: twenty-nine patients presented meniscal lesions (90.6%), among which 20 were lesions of the medial meniscus alone (68.9%), five were lesions of the lateral meniscus alone (17.2%) and four were lesions of both menisci (13.8%).In relation to symptoms, 11 of the 32 patients reported pain on making effort (34.4%) and six reported sporadic edema (18.75%).In the physical examination, atrophy of the quadriceps muscle of the thigh was found in 20 patients (62.5%), but the atrophy was only considered severe in one patient (>2 cm difference in relation to the opposite side).For the anterior translation of the tibia in relation to the femur was found to be a mean of 2.09 mm in relation to the contralateral side (1-6 mm).One patient presented an increase in translation of 6 mm, relating to repeated tearing of the acl, and underwent revision surgery after assessment and inclusion of the data for analysis.Conclusion: the patients who underwent acl reconstruction by means of the anteromedial transportal using the rigidfix system presented satisfactory clinical results over the length of follow-up evaluated.However, the risk of lesions of the joint cartilage from the distal rigidfix pin needs to be taken into consideration when the technique via an anteromedial portal is used.Further studies with larger numbers of patients and longer follow-up times should be conducted for better evaluation.

• 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: 9210050
• MDR Text Key: 175940354
• Report Number: 1221934-2019-58883
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 10/04/2019

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: 10/04/2019
• Initial Date FDA Received: 10/18/2019
• 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