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); Swelling (2091)

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 product: unknown bio-intrafix.(b)(4).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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: antonio maestro et al, 2012, ¿acl reconstruction with single tibial tunnel: single versus double bundle", j knee surg; 25, page no 237¿244, spain.The study emphasizes on evaluating the clinical behavior and level of stability of patients treated to repair a ruptured acl using either single or double bundle techniques with a single tibial tunnel.The patients evaluated on course of this study: 35 patients with a ruptured acl treated using a db technique with a single tibial tunnel (db- 3t) was studied and followed for at least 2 years.A control group of 36 nonconcurrent patients in which the ruptured acl was repaired using the conventional sb technique was selected.Patients with concomitant ligament, or severe meniscal or chondral lesions were also excluded.Delay between injury and ligament reconstruction was similar for both groups, at around 3 weeks: 22.08 days in the db-3t group compared with 25.16 days in the sb group.Cases with more severe meniscal or chondral lesions were excluded from the study.The db-3t group consisted of 23 men and 12 women with an average age of 22 years 11 months, while the sb group included 28 men and 8 women with an average age of 26 years 9 months.The article describes the following procedure: the techniques used in all cases included acl reconstruction through autologous hamstring tendons (gracilis and semitendinosus) with identical approaches.The devices involved were: rigidfix acl cross pin device was used for femoral fixation and intrafix was used for tibial fixation systems.Complications mentioned in the article were: cyclops syndrome and repetitive effusion (1 case each) were observed in the double bundle group.1 case of extra- articular infection with (b)(6)) in the donor area and one case of repetitive effusion.From the review of the article, it could be concluded that the rigidfix acl cross pin and intrafix devices mentioned above could be involved in repetitive effusion.

• 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: 8835852
• MDR Text Key: 152485604
• Report Number: 1221934-2019-57825
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/05/2019

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: 07/05/2019
• Initial Date FDA Received: 07/29/2019
• 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