• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US RIGIDFIX FEM2.7MM B/T/B XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK LLC US RIGIDFIX FEM2.7MM B/T/B XPIN SOFT-TISSUE ANCHOR, BIOABSORBABLE Back to Search Results
Catalog Number 210127
Device Problems Break; Migration or Expulsion of Device
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: cossey, aj. , et al. (2005) "loose intra-articular body following anterior cruciate ligament reconstruction", the joumal of arthroscopic and related surgery, vol. 21, no. 3, pages 348-350 (australia). The study emphasizes on a case of intra-articular fracture of a bioabsorbable fixation device from the femoral tunnel in an anterior cruciate ligament reconstruction using a bone-tendon-bone graft. This case raises concern about the potential for breakage and resultant loose body formation that may occur after bioabsorbable cross-pin fixation and, particularly, the associated chondral damage that can occur if early intervention is not conducted. The patients evaluated on course of this study: a (b)(6)-year-old man initially underwent acl reconstruction in (b)(6) 2002. The acl reconstruction was performed using bone-tendon-bone graft, the graft being fixed with polylactic acid bioabsorbable rigidfix cross pins to secure the graft in both the femoral and tibial tunnels. After surgery, the patient underwent a routine rehabilitation regimen under the guidance of the physiotherapists. This was uneventful and he was discharged from clinical follow-up having resumed competitive sports 7 months postoperatively. However, 13 months after his reconstruction, the patient experienced pain on the inner aspect of his knee as well as intermittent episodes of locking. He disclosed no symptoms of instability or swelling. An initial diagnosis of synovial impingement secondary to postoperative fibrosis was made and he was treated with a course of nonsteroidal anti-inflammatory drugs and an intra-articular injection of local anesthetic and steroid. Arthroscopy was performed 1 month after his representation and a loose body consistent with a fragment of the rigidfix cross pin used for femoral graft fixation was found in die medial compartment of the knee. Following arthroscopy, the patient was symptom free for a period of 3 weeks. At this stage, he started to experience symptoms of locking. A magnetic resonance imaging scan was requested and it showed another loose body within the knee joint. Repeat arthroscopy was performed 6 weeks following the earlier procedure. Because of the translucency of die rigidfix loose body, difficulties arose locating it, but another piece of rigidfix was removed, this time from the lateral gutter. The article describes the following procedure: anterior cruciate ligament reconstruction. The devices involved were: bioabsorbable rigidfix cross pin (mitek, (b)(4)). Complications mentioned in the article were: patient experienced episodes of locking and medial joint pain and loose body within the knee joint.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRIGIDFIX FEM2.7MM B/T/B XPIN
Type of DeviceSOFT-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 Key9145658
Report Number1221934-2019-58757
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 09/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number210127
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
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 Unkown

Patient TREATMENT DATA
Date Received: 10/02/2019 Patient Sequence Number: 1
-
-