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 Tissue Damage (2104)

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: yujie liu, et al, 2008 ¿reconstructing anterior cruciate ligament with hamstring tendon fixed with rigid fix cross pins at femoral and tibial end¿, 2034 national medical journal of china 89 (29) (china).The purpose of the study was to discuss the efficacy of securing femoral end and tibial end with rigid fix systems in the anterior cruciate ligament reconstruction with hamstring tendons.32 patients with cruciate ligament injury are included in this study, among them 18 are males and 14 are females, with an average of 28 years old (20 to 45), including 24 sport injuries and 8 car accidents.The average duration between injury and operation is 3.6 months (2.5 to 6 months).Prior to the surgery, knee joint mri and x-ray exam is performed.With arthroscopy, 19 femoral attachment fractures of acl and 13 tibial attachment fractures of acl are discovered; 3 patients are combined with medial meniscus injury and 4 patients are combined with medial cartilage injury.Autogenous semitendinosus tendon and gracilis tendon are harvested and pre-expanded.Then tendons are braided into 5 strands in 18 patients, 4 strands in 14 patients.Tendon diameter is around 7-8 mm.Tibial tunnel is located at intercondylar and then created, which is positioned 10:30 - 11:00 to the intercondylar fossa.Guidance wire is inserted, and femoral tunnel is drilled along it for 30 mm in depth.Femoral rigidfix holes are drilled with the guidance of rigid fix introducer, and 2 catheters are placed.Guidance rod is placed at the medial portal of femoral tunnel, aligned with subchondral bone to drill tibial rigid fix pin holes, and 2 catheters are placed there.Tendons are introduced into the bone tunnel, and 2 femoral end rigid fix pins are inserted from the near to the distant.With the knee joint extension and the tendons straining, 2 tibial rigid fix pins are placed.Sutures on the tendon tails are secured with knot at tibial bone bridge.The device involved: 2 tibial rigid fix cross pins.Post-operation follow up is performed for 16 months in average, which indicate that knees are stable and function well.For lysholm functional scaling, it is 62.5 in average pre-operation, and 94.5 in the last follow up, with 32 increases.Complications mentioned in the study: for rulemetr test, tibial dislocation less than 2 mm is observed in 28 patients, less than 4 mm is observed in 4 patients.Lachman test negative is indicated in 30 patients, and weak positive is indicated in 2 patients.In accordance with knee joint efficacy assessment criterion, 30 are categorized as excellent, and 2 are categorized as good.Post-operative infection is not discovered.Reactive synovitis is indicated in 2 patients, and the symptom is disappeared with flushing treatment.From the review of the article it can be concluded that rigid fix pins are utilized to secure femoral and tibial end of hamstring tendon graft in acl reconstruction, which prevents the tendon cutting and tunnel expansion, facilitate the close contact between tendon and tunnel, and benefit tendon-bone reunion.This approach is practical.

• 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: 9191874
• MDR Text Key: 174489788
• Report Number: 1221934-2019-58988
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 10/13/2019
• Initial Date FDA Received: 10/15/2019
• 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