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 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: lee, hj., et al (2010), comparison of clinical results and second-look arthroscopy findings after arthroscopic anterior cruciate ligament reconstruction using 3 different types of grafts, the journal of arthroscopic and related surgery, vol.26 no.1, pages 41-49 (korea, south).The study emphasizes on comparing the statement of the knee joint and second-look arthroscopic findings of the graft after anterior cruciate ligament (acl) reconstruction using bone-patellar tendon-bone (bptb) allografts, tibialis anterior tendon (ta) allografts, and hamstring tendon (ha autografts) by physical and quantitative testing and by second-look arthroscopy.The patients evaluated on course of this study: between march 2000 and february 2006, a total of 338 patients who had undergone anterior cruciate ligament reconstruction were included in the study.The patients were divided into 3 groups: bptb allografts were used in 60 cases (51 men and 9 women); ta allografts were used in 153 cases (127 men and 26 women); and ha autografts were used in 125 cases (99 men and 26 women).The article describes the following procedure: an arthroscopic anterior cruciate ligament (acl) reconstruction.The device involved was: bioabsorbable cross pins (rigidfix system; depy mitek, raynham, ma).Complications mentioned in the article: graft failure in 5 cases (bptb), and another 5 cases (ta).Revision were performed in these cases.Second-look arthroscopy: abnormal laxity in 1 case (bptb), 2 cases (ta) and 3 cases (ha).Partial tear in 1 case (bptb), 5 cases (ta), 3 cases (ha).Impingement or presence of a cyclops lesion in 3 cases (bptb), 7 cases (ta) and 6 cases (ha).

• 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: 9271533
• MDR Text Key: 185118677
• Report Number: 1221934-2019-59405
• 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: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• 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: 10/30/2019
• 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