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 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.

Event Description

This report is being filed after the review of the following journal article: lee, b., et al (2010), delayed foreign body reaction due to bioabsorbable pins used for femoral fixation in anterior cruciate ligament reconstruction: a case report, the american journal of sports medicine, vol.38 (1), pages 176-180 (korea, south).This study emphasizes on: to report a delayed, extensive foreign body reaction to the rigidfix pin with osteolytic femoral tunnel widening and huge extraarticular fluid collection 1 year and 10 months after the acl reconstruction.The patients evaluated on course of this study: a case report of a (b)(6) man, a soccer player, who suffered a noncontact twisting injury to his right knee 3 weeks before presentation at the clinic.At the time, he felt a pop and was unable to continue with the game.His knee became swollen a few hours after the injury.At the presentation, the findings of physical and radiological examinations suggested a complete tear of the acl and tearing of the medial and the lateral menisci.The article describes the following procedure: arthroscopic acl reconstruction with autogenous gracilis and semitendinosus hamstring tendons was performed.The torn medial meniscus was repaired by using the inside-out technique, and the torn lateral meniscus was trimmed to create a stable border.The devices involved were: the rigidfix implant for the femoral fixation, while a bioabsorbable interference screw and a ligament staple for tibial fixation.Complications mentioned in the article were: one year and 10 months after the surgery, he was seen with a large, slightly tender mass at the lateral aspect of the distal thigh, which had developed 4 months before (figure 1).A physical examination showed mild joint effusion, and grade 1 lachman and grade 1 pivot-shift test result, or unchanged stability as compared with his previous visit.Plain radiographs revealed an osteolytic femoral tunnel dilatation, and an mri study disclosed an extensive cystic lesion with osteolytic femoral tunnel widening (figure 2).Arthroscopy demonstrated that the intra-articular findings were relatively clear without fulminant synovitis, which contrasted with extensive bony pathological changes at the femoral tunnel and substantial extra-articular fluid collection.The reconstructed acl was taut and covered by a synovial lining.Intraoperatively, two pieces of a broken rigidfix pin fragment were found inside the cyst.

• 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: 9186784
• MDR Text Key: 173012557
• Report Number: 1221934-2019-58944
• 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: 10/09/2019

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?: 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: 10/09/2019
• Initial Date FDA Received: 10/14/2019
• 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