MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN RIGIDFIX CROSS PIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK RIGIDFIX

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 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.[(b)(4)].

Event Description

This report is being filed after the review of the following journal article: nam-hong choi, et al, 2007 ¿do broken cross-pins compromise stability after anterior cruciate ligament reconstructions with hamstring tendons?¿, the journal of arthroscopic and related surgery, vol.23, no.12, pp 1334-1340 (south korea).The purpose of this prospective study was to define the relation between the integrity of cross-pin femoral fixation and stability after anterior cruciate ligament (acl) 'reconstructions.Thirty-one consecutive acl reconstructions were performed with hamstring tendons fixed with bioabsorbable cross-pin femoral fixation.All patients underwent magnetic resonance imaging at 6 months postoperatively to assess the status of the cross-pin fixation.Clinical evaluations were performed via the lachman and pivot-shift tests.The side-to-side differences were measured by kt-1000 testing (medmetric, san diego, ca) at 2 years postoperatively.The patients were divided into 2 groups according to the status of the cross-pin.Group 1 consisted of those in whom the cross-pins were intact, and group n had broken cross-pins.The study describes the following procedures: the femoral tunnel was prepared via a transtibial technique.A 5- to 7-mm femoral offset guide is used to leave a i - to 2-mm posterior wall.The femoral tunnel is drilled to a depth of 30 mm at the 10:30 position in the right knee or the 1:30 position in the left knee.The rigidfix guide frame was inserted into the tibial and femoral tunnel, with the window of the guide frame jig facing the center of the lateral femoral condyle.The sleeve-trocar assembly was inserted through the jig, and the guide frame was removed, and 2 sleeves positioned.The arthroscope was inserted through the anteromedial portal or the tibial tunnel to inspect the femoral tunnel.The guidewires were inserted through each sleeve, and central placement of the guidewires within the femoral tunnel was confirmed.The devices involved were: rigidfix (depuy mitek, raynham, ma).Intrafix system (depuy mitek).There were 19 patients in group 1 and 12 (38.7%) in group ii.Among the 24 cross-pins used in the 12 patients in group ii, 18 were broken.Among the patients in group 1, the tip of the cross-pin was inside the posterior cortex of the distal femur in 7 (36.8%) and outside in 12 (63.2%).In group ii the tip of the cross-pin was outside the posterior cortex of the distal femur in all patients.This number was significantly higher than that in group i (p =.017).Group i had significantly lower kt-1000 measurements than group tl (p =.003).The mean kt-1000 side-to-side difference was 0.47 mm in group i and 3.0 mm in group ii.The lachman and pivot-shift test data revealed no significant differences between the 2 groups (p =.467 and p =.796, respectively).This study showed that breakage of bioabsorbable cross-pins is a relatively common phenomenon.Broken cross-pins were a factor relating to laxity after acl reconstructions with hamstring grafts.Posterior direction of the cross-pin may be a cause of pin breakage.

Manufacturer Narrative

Depuy is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy or its employees that the report constitutes an admission that the device, depuy , or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Upon complaint review, it was determined that the initial reporter facility name and address were inadvertently missed on the initial report; therefore, all fields have been updated to reflect the correct information.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.

• 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
• MDR Report Key: 9146431
• MDR Text Key: 166899306
• Report Number: 1221934-2019-58774
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK RIGIDFIX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention