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 Cyst(s) (1800)

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.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: ahn, jh., et al.(2013), "single-bundle transtibial posterior cruciate ligament reconstruction using a bioabsorbable cross-pin tibial back side fixation", vol.21, no.5., pages 1023-1028 (korea).The study emphasizes on a group of patients who underwent transtibial posterior cruciate ligament (pcl) reconstruction using a bioabsorbable cross-pin tibial back side fixation method.The patients evaluated on course of this study: thirty patients underwent transtibial pcl reconstruction using a bioabsorbable cross-pin tibial back side fixation method from 2005 to 2008.Pcl reconstruction was performed in patients with painful instability with more than a 10 mm side-to-side difference in stress radiographs after initial conservative treatment.Eight of the 30 patients had plri.A posterolateral comer sling operation was performed on two patients with a semitendinous autograft and on six patients with a tibialis allograft.Twenty-two patients were reconstructed using a tibialis allograft and 8 with a 4-strand hamstring autograft.Of the original 33 patients (33 knees) eligible for inclusion, three patients (three knees, 9%) were lost to follow-up.Follow-up was recommended at 2 and 6 weeks, 3, 6, and 12 months, and annually thereafter.Lysholm knee scale and subjective and objective international knee documentation committee (ikdc) scores were used to document clinical outcomes.Stability was evaluated using a telos device (austin and associates, fallston, md) at 150 n and 90° of knee flexion with one decimal record.The article describes the following procedure: routine diagnostic arthroscopy was performed around intraarticular structures.Meniscal surgery, chondroplasty, or microfracture was performed.The devices involved were: unknown rigid fix cross guide pin is introduced by placing the drill guide at an angle of 50°-55° aiming at the distal-lateral portion of the pcl tibial attachment site (approximately 1 cm below the joint line).Complications mentioned in the article were: of these 20 patients, 7 exhibited a tibial tunnel complication (an abnormal signal or cyst formation).A copy of this literature article is attached to this medwatch report.

• 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: 9134474
• MDR Text Key: 161553372
• Report Number: 1221934-2019-58664
• 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
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• 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
• Date Manufacturer Received: 09/17/2019
• 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