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); Swelling (2091); Synovitis (2094); Discomfort (2330); No Code Available (3191)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an 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.(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.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: kee-byung lee, et al , 2010 "delayed intra-articular migration of the intrafix outer sheath after anterior cruciate ligament reconstruction: a case report" elsevier b.V.The knee 18, page no-347-349, south korea.The study emphasizes on the observation of the delay of intra-articular migration of the intrafix outer sheath after anterior cruciate ligament reconstruction.The patients evaluated on course of this study: a (b)(6)-year-old female with a 6-month history of left knee pain after a twisting injury was taken as a subject.Physical examination revealed positive lachman test, tenderness at the lateral joint line and mild effusion.Magnetic resonance imaging (mri) revealed an acl discontinuity and a tear of the discoid lateral meniscus.Acl reconstruction was performed.At 5 months after surgery, the patient experienced a sudden catching sensation and a slight pain without any obvious twisting or trauma.At 6 months after surgery, extension deficit was 20°.At arthroscopy, intra-articular migration of the outer sheath from the tibial tunnel and reactive synovitis were observed.The article describes the following procedure: acl reconstruction was performed with an 8.5-mm tibial allograft tendon.Partial menisectomy and arthroscopy was also performed.The devices involved were: the graft was secured with a bioabsorbable rigid fix cross pins (depuy mitek, raynham,ma) on the femoral side and non-absorbable intrafix (dupey mitek, westwood, ma) with a post-tie staple on the tibial side.Complications mentioned in the article were: 5 months after surgery, the patient noted a sudden catching sensation and a slight pain with swelling in her operated knee with no obvious twisting or trauma.Mild effusion.Lateral joint line tenderness.Remnant lateral meniscal tear.Reactive synovitis.

• 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: 8775288
• MDR Text Key: 150543155
• Report Number: 1221934-2019-57576
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/18/2019

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: 06/18/2019
• Initial Date FDA Received: 07/10/2019
• 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
• Patient Age: 48 YR