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); 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: abdul g.Dudhniwala et al, 2012, ¿lateral meniscal tear resulting from the femoral cross-pin used for hamstring graft fixation in anterior cruciate ligament reconstruction¿, the knee volume 19 number 6 pages 951-952, united kingdom.The study emphasized that in using cross-pin system there is known incidence of breakage.The study recommends a low threshold to investigate with a mri scan any new symptoms following acl reconstruction with cross pin fixation.The patients evaluated on course of this study: a (b)(6) man presented with history of injury to his right knee whilst playing football resulting in a complete acl tear, he underwent acl reconstruction with a four-strand hamstring tendon autograft.The graft was fixed on the femur using two bioabsorbable cross-pins (rigidfix®, depuy mitek inc.) and on the tibia with an intrafix screw (depuy mitek inc) and sheath.The article describes the following procedure: diagnostic arthroscopy performed during this procedure did not reveal any other meniscal.Chondral or ligament injury.No untoward events were encountered during the operation and satisfactory graft fixation and knee stability were achieved.Following this he underwent routine acl rehabilitation under the supervision of physiotherapists, achieving full knee range of motion and knee stability on clinical examination.He was discharged from clinical follow up and started participation in sporting activities within 9 months of acl reconstruction.The devices involved were: two bioabsorbable cross-pins (rigidfix®, depuy mitek inc.) and on the tibia with an intrafix screw (depuy mitek inc).Complications mentioned in the case report were: the patient presented 13 months following the acl reconstruction with symptoms of knee pain, locking and catching.He did not recall any specific injury to the knee which initiated these symptoms.On clinical examination of the knee there was a mild joint effusion, tenderness over the lateral joint line and a stable acl on pivot shift and lachman test.To investigate these new symptoms an mri scan of the knee was performed which showed lateral end of the distal femoral cross-pin abutting the lateral meniscus (fig.1), tear in the lateral meniscus, and breakage of the distal cross pin at the bone-graft junction.There was a minimal joint effusion and an intact acl graft without any evidence of graft impingement, tunnel osteolysis or cyclops lesion.He underwent a knee arthroscopy which revealed the broken distal cross-pin which was pistoning in its tunnel and was in contact with the lateral meniscus (fig.2).There was a tear in the lateral meniscus at this site of abutment with cross pin and inflammation of the surrounding synovium.The acl graft was intact and functional.The broken cross-pin was removed, and the lateral meniscus was repaired with meniscal sutures.Postoperatively his symptoms resolved, and he returned to his activities after rehabilitation.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Upon complaint review, it was determined that 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.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: UNKNOWN RIGIDFIX CROSS PIN
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9186124
• MDR Text Key: 173018002
• Report Number: 1221934-2019-58924
• 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
• Type of Report: Initial,Followup
• 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RIGIDFIX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/14/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR