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.

Event Description

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 acl reconstruction surgery using flexor tendons by means of the anteromedial transportal technique, with the rigidfix system for femoral fixation and evaluating the positioning of the entry of the rigidfix pins, by means of 3d tomography.The patients evaluated on course of this study: thirty-two patients were selected for this study.All of them were operated by the same surgical team between january 2009 and july 2010.The patients included underwent acl reconstruction surgery.If another type of graft was used for acl reconstruction (patellar tendon, quadriceps tendon or an allograft); if a route other than the anteromedial transportal route was used for constructing the femoral tunnel; if the follow-up was less than 24 months; or if another method was used for femoral fixation of the graft were excluded from the study.32 patients with a mean postoperative follow-up of 30 months (range: 24-36 months) were selected.There were 28 males and four females.Their mean age was 33.1 years (range: 16-56) at the time of the surgery.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%).Partial meniscectomy was performed on the lesions in all cases.The mean preoperative lysholm score was 74.53 (range: 43-83) and the mean postoperative score was 87.81 (range: 53-95), and this result can be considered good.The mean subjective ikdc was 74.16 (range: 37.93-91.95) before the operation and 83.72 (57.5-100) after the operation.The point of entry of the proximal pin was outside of the cartilage in all the patients.The point of entry of the distal pin was in the peripheral region of the joint cartilage in seven patients (21.87%), at the border of the cartilage in nine (28.12%) and outside the cartilage in 16 (50%).The mean lysholm score was 89.85 (range: 89-93) and the mean ikdc score was 79.95 (range: 65.5-95.4); in those in whom the distal pin was at the border of the cartilage, the mean was 88.33 for the lysholm score (range: 53-95) and 86.2 for the ikdc score (range: 69-100), while in those in whom the distal pin was positioned outside of the cartilage, the mean lysholm score was 87.2 (range: 68-95) and the mean ikdc score was 83.82 (range: 62-98.9).The article describes the following procedure: reconstruction of the anterior cruciate ligament by means of an anteromedial portal and femoral fixation.The devices involved were: rigidfix for femoral fixation and biointrafix (mitek, norwood, ma, usa) for tibial fixation.Complications mentioned in the article were: 11 of the 32 patients reported pain on making effort (34.4%).Six reported sporadic edema (18.75%).In the physical examination, 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).One patient presented an increase in translation of 6 mm, relating to repeated tearing of the acl, and underwent revision surgery after assessment.

• 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: 9254884
• MDR Text Key: 180847474
• Report Number: 1221934-2019-59313
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• 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
• Date Manufacturer Received: 10/24/2019
• 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