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); Tissue Damage (2104); 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.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 report is being filed after the review of the following journal article: dirk stengel et al, 2009, ¿functional outcomes and health-related quality of life after robot-assisted anterior cruciate ligament reconstruction with patellar tendon grafts¿, knee surgery sports traumatology arthroscopy volume 17 pages 446-455, (germany).The purpose of the study was to report complication rates, knee function, and health-related quality of life in patients who had undergone robot-assisted acl replacement with patellar bone-tendon-bone grafts and were followed-up for a minimum of four years.Between 2000 and 2003, 152 patients underwent acl replacement with the assistance of the computer assisted surgical planning and robotics system (caspar, ortomaquet, germany) at our hospital.After minimal invasive pin placement in both the tibia and femur, computed tomography was used to register anatomical landmarks and to plan graft tunnel alignment.The robot was used to drill tibial and femoral tunnels in an outside-in fashion according to pre-operative planning.There was one procedure-specific serious adverse event (i.E., an intraoperative transection of the posterior cruciate ligament).The article describes the following procedure: acl-repair consisted of four distinct phases, i.E., locator pin insertion, ct-imaging and image processing, virtual planning, and robotic drilling of the graft tunnels.The device involved: two resorbable rigidfix pins (johnson & johnson, dusseldorf, germany).The mean kt-1000 side-to-side difference was 0.89 [95% confidence interval (ci) 0.52-1.26] mm.Eight and five patients had a positive lachman and pivot shift test, respectively.The lysholm-score averaged 86 (95% ci 83- 89) points.Excellent, good, fair, and poor outcomes were reported by 38, 32, 20, and 10 patients.The lefs averaged 85 (95% ci 82-88) points.The mean sf36 physical component score was 48.4 (95% ci 46.5-50.3), indicating residual deficits compared to the population norm.Complications mentioned in the study: 3 superficial wound infection resolved under antibiotic treatment.2 dislocation of the tibial bone block, requiring revision.2 transient paraesthesia of the operated leg.2 deep venous thrombosis resolved under anticoagulation.1 post-operative arthritis requiring arthroscopic revision 1 compartment syndrome, requiring fasciotomy.1 arthrofibrosis, requiring arthroscopic debridement.Occurring 1, 2, and 3 years after the index procedure: 3 graft failure requiring revision.Occurring 5, 6, and 7 years after the index procedure: 3 traumatic graft rupture after sports injury.Classified as serious, procedure-specific adverse event (sae): 1 transection of the posterior cruciate ligament.

• 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: 9262478
• MDR Text Key: 183568124
• Report Number: 1221934-2019-59360
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• 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: 10/28/2019
• 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