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 Tissue Damage (2104); Not Applicable (3189)

Event Date 02/25/2010

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: lee, sh., et al (2010), combined reconstruction for posterolateral rotatory instability with anterior cruciate ligament injuries of the knee, knee surgery sports traumatology arthroscopy, vol.18, pages 1219-1225 (korea, south).Doi: 10.1007/s00167-010-1078-4.The study emphasizes on evaluating the clinical outcomes and technical aspects of combined acl-pcl reconstruction using hamstring tendon autografts.The patients evaluated on course of this study: from 2002 to 2007, a total of 44 knees (41 males and 3 females), with a median age of 29 years (range 16-53) at the time of surgery, who underwent a combined reconstruction for posterolateral rotatory instability with anterior cruciate ligament injuries of the knee were included in the study.The article describes the following procedure: a combined reconstruction for posterolateral rotatory instability with anterior cruciate ligament injuries of the knee.The devices involved were: rigidfixtm femoral fixation and mitek intrafixtm tibial fixation (mitek product, (b)(4), usa), femoral fixation system and bioabsorbable interference screw.Complications mentioned in the article: 2 patients had knee joint stiffness; 1 of whom was subjected to an adhesiolysis performed arthroscopically 6 months after surgery; on the final follow-up, both patients could not squat fully.1 patient was subjected to an arthroscopic examination because of a hemarthrosis and loss of motion due to reinjury 18 months after surgery; result revealed a hematoma due to a partial rupture of the acl graft tendon and a debridement was performed.2 patients developed an infection of the knee joint that healed after arthroscopic irrigation and debridement without graft removal.

• 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: 9255726
• MDR Text Key: 183567545
• Report Number: 1221934-2019-59329
• 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: 10/25/2019

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: 10/25/2019
• 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