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 Pain (1994); Loss of Range of Motion (2032)

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 screws.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: ventura, a., et al (2010), synthetic grafts for anterior cruciate ligament rupture: 19-year outcome study, the knee, vol.17(2), pages 108-113 (italy).The study emphasizes on reporting long-term results after artificial ligaments implantations in the knee.The patients evaluated on course of this study: between 1986 and 1990, a total of 126 patients underwent anterior cruciate ligament (acl) reconstruction using artificial ligaments.Only 90 sportsmen (64 males and 26 females), aged 15 to 40 years old, were included in the study.Twenty-seven patients had chronic tears and the ligament was implanted as a prosthesis, by mini-arthrotomy using an ¿over the top¿ technique with staples fixation.In addition to the acl damage, 2 patients had a complete rupture of the medial collateral ligament (mcl).Fifty-one patients were contacted after an average time of 18.75 years from surgery (42 men and 9 women).Of the 51 followed up patients, 14 were diagnosed to have an artificial acl rupture; revision surgery was considered the treatment of choice.The article describes the following procedure: an artificial acl reconstruction using an ¿over the top¿ technique.In 11 cases, the graft was implanted as a prosthesis and in 40 cases, it was augmented together with a bone-patellar tendon-bone (bptb) graft.The stabilization as carried out using three different synthetic grafts: trevira-hochfest (telos, sarl, marburg, germany), proflex (protek ltd, bern, switzerland) and pro-pivot.In 63 cases, a bptb augmentation method was chosen: the central third of the patellar tendon was harvested, together with its bone insertions.For the revision surgery, the procedure included a first surgical step to remove the artificial graft and the staples, followed by autologous acl reconstruction 6 months later.Acl reconstruction was performed either with hamstring tendons of bptb in local anesthesia.The devices involved were: guide wires and 2 transcondylar pins (rigidfix equipment, mitek, johnson & johnson, norwood, ma), and interference screws.Complications mentioned in the article: 2 patients had an important impairment in motion; flexion deficit >20° and 10° extension deficit.Patellofemoral pain was reported in 11 cases.Osteoarthritis was detected in all patients; 7 (grade 1), 12 (grade ii), 20 (grade iii), 7 (grade iv) and 5 (grade v) according to ahlback classification criteria.

• 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: 9234950
• MDR Text Key: 177639725
• Report Number: 1221934-2019-59195
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/21/2019

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: 10/21/2019
• Initial Date FDA Received: 10/24/2019
• 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