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 Problems Unspecified Infection (1930); Loss of Range of Motion (2032); Not Applicable (3189)

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 bio-intrafix.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: noh, jh., et al (2011), anterior cruciate ligament reconstruction using 4-strand hamstring autograft: conventional single-bundle technique versus oval-footprint technique, the journal of arthroscopic and related surgery, vol.27 no.11, pages 1502-1510 (south korea).The study emphasizes on comparing the outcomes of a conventional single-bundle anterior cruciate ligament (acl) reconstruction technique with those of an oval-footprint (modified) technique, which makes the femoral and tibial tunnels elongated, more like the footprints of the native acl.The patients evaluated on course of this study: 74 patients who were diagnosed with acl rupture and underwent acl reconstruction between 2006 and 2008 and underwent partial meniscectomy for meniscus tear or who had medial collateral ligament injury that was treated conservatively were included in the study.The patients underwent conventional (group i; 40 cases) or modifies (group ii; 34 cases) single-bundle acl reconstruction.38 patients in group i and 32 patients in group ii were followed-up clinically and radiographically for at least 2 years.Ankle pump exercise and quadriceps-setting exercise began on postoperative day 1.Continuous passive motion from 0° t 50° began on postoperative day 2 and advanced to 90° the second postoperative week as tolerated.Partial weight bearing was allowed on postoperative day 2 and full weight bearing thereafter.Running was permitted 3 months postoperatively, competitive sports 6 months postoperatively, and full sports activity when the functional evaluations such as strength, stability, and range of motion of the knee were met 9 to 12 months postoperatively.The article describes the following procedure: acl reconstruction, conventional single-bundle technique and oval-footprint (modified) technique.The devices involved were: rigidfix guide system (depuy mitek, (b)(4)), rigidfix cross pins, intrafix device (depuy mitek), 2 strong no.2 ethibond sutures and no.5 ethibond suture.Complications mentioned in the article: 1 patient in group i developed an infection of the reconstructed knee.1 patient in group ii lost 5° of extension.1 patient in group ii was injured again after playing basketball and underwent revision surgery.

• 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: 9186503
• MDR Text Key: 173644875
• Report Number: 1221934-2019-58932
• 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: 10/09/2019

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: 10/09/2019
• Initial Date FDA Received: 10/14/2019
• 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