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

Catalog Number 210127

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); 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: 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.

Manufacturer Narrative

Depuy is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy or its employees that the report constitutes an admission that the device, depuy , or its employees caused or contributed to the potential event described in this report.Correction: a2, a3: the patient age at the time of event and sex were inadvertently missed on the initial report; therefore, both fields have been updated accordingly to reflect the correct information.E1: initial reporter facility name and address were inadvertently missed on the initial report; therefore, both fields have been updated accordingly to reflect the correct information.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.

Manufacturer Narrative

Depuy is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy or its employees that the report constitutes an admission that the device, depuy , or its employees caused or contributed to the potential event described in this report.H10 additional narrative: additional information: product code was received; therefore, brand name, catalog number, udi and 510(k) were updated accordingly.Udi: (b)(4).The lot number is currently unavailable; therefore, the exp date is unavailable.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.

• Brand Name: RIGIDFIX FEM2.7MM B/T/B XPIN
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9145658
• MDR Text Key: 167570424
• Report Number: 1221934-2019-58757
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210127
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 10/22/2019; 11/13/2019
• Supplement Dates FDA Received: 10/24/2019; 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR