MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANTS - RIGIDFIX; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK - IMPLANTS - RIGIDFIX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Foreign Body In Patient (2687)

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 sutures.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: boden, ra., et al (2013), loose body following cross-pin fixation for anterior cruciate ligament reconstruction, journal of orthopaedics and traumatology, vol.14(2), pages 155-157 (united kingdom).Doi: 10.1007/s 10195-012-0194-y.The study emphasizes on a (b)(6) fit and well male who sustained a complete left acl rupture (in (b)(6) 2001) due to a rotational soccer injury and was confirmed at subsequent arthroscopy.The patient elected for a reconstruction after a course of physiotherapy and a period of non-operative treatment.Postoperatively, the patient made a full recovery and returned to sporting activity at 6 months.However, developed an acute collection on the medial side of the knee three months ((b)(6) 2008) the operation.The case report describes the following procedure: an acl reconstruction was performed 3 years after the initial injury ((b)(6) 2004) using bone patellar tendon bone (btb).The devices involved were: two rigidfix cross pins placed from the lateral side of the femur.Tibia was fixed with a 20mm x 9mm metal interference screw.A concomitant posterior 1/3 tear of the medial meniscus was repaired with 2 mitek bioabsorbable sutures.Complications mentioned in the article were: the patient developed an acute collection on the medial side of the knee overlying the medial femoral condyle forty-two months ((b)(6) 2008) after the procedure.The rigidfix implant was retrieved intact and later fractured.

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.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.Correction: a2: upon complaint review, it was determined that the patient age at the time of event and age unit was inadvertently missed on the initial report.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: UNK - IMPLANTS - RIGIDFIX
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9141247
• MDR Text Key: 167312806
• Report Number: 1221934-2019-58732
• 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,Followup
• Report Date: 09/24/2019

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 - IMPLANTS - RIGIDFIX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 10/08/2019; 11/08/2019
• Supplement Dates FDA Received: 10/09/2019; 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR