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 Inflammation (1932); Synovitis (2094)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown rigidfix cross pin.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: unk - guides/sleeves - rigidfix, 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.

Event Description

This report is being filed after the review of the following journal article: bailunhao et al, 2007, "application of arthroscopic rigidfix cross pins and intrafix screw for posterior cruciate ligament reconstruction" journal of china medical university, 36(3): page no-334-335, china.The study emphasizes on the demonstration of the application of arthroscopic rigidfix cross pins and intrafix screw for posterior cruciate ligament reconstruction.The patients evaluated on course of this study: this group of patients include 21 male and 15 female, their age range from 15 to 51 and averages to 30.4.All of them have unilateral injury, history of trauma which includes traffic trauma, injured by heavy object, sport injury, high falling injury, simple pcl injury, medial collateral ligament mcl injury, lateral collateral ligament injury, medial meniscus injury, lateral meniscus injury, neurovascular injury.The article describes the following procedure: posterior cruciate ligament reconstruction.After the operation the patients have been followed up for 6 to 26 months, and the average follow-up time is 10.4 months.The ikdc grade was calculated before and after the surgery and compared.The devices involved were: a guiding rod whose diameter can match the tunnel (rigidfix cross pin guiding device), is inserted into the shank bone channel using the positioning pin.Rigidfix cross pin guiding device is installed.One piece of absorbable rigidfix cross pin is also used.Intrafix pin sheath is used in intrafix expansion screw insertion cone-shaped.Intrafix pin is inserted into the pin sheath in intrafix expansion screw insertion.The complications mentioned in the article were: local fluid accumulation in 4 patients postoperatively.Arthrosynvitis and knee joint swells in 4 patients.

• 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 ; 5088808100
• MDR Report Key: 8822711
• MDR Text Key: 152077160
• Report Number: 1221934-2019-57770
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/04/2019

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: 07/04/2019
• Initial Date FDA Received: 07/24/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention