MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN GII ANCHOR; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number UNK GII ANCHOR

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Unspecified Infection (1930); 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: maheshwari, a., et al.(2012) "extensile posterior approach to the ankle with detachment of the achilles tendon for oncologic indications", fool & ankle international, vol.33, no.5, pages 430-435 (usa).This study emphasizes on describing this novel approach and to discuss its preliminary results.The patients evaluated on course of this study: between 1986 and 2009, 181 cases of foot and ankle tumors were surgically treated.Before the year 2000, patients with tumors of posterior ankle were treated with posteromedial and/or posterolateral incisions with additional anterior incision as needed.In 2000, the senior author developed an extensile posterior approach to the ankle with detachment of the achilles tendon to facilitate exposure and minimize wound complications.This approach has been utilized in 6 patients.The diagnosis was pigmented villonodular synovitis (5) and chondroblastoma (1).At a mean of 6 (range, 2 to 10) years follow-up, all patients were free from tumor.All patients could walk an unlimited amount without any support.There were no problems with achilles incompetence.The mean musculoskeletal tumor society score was 97 ± 4.2% (range, 90 to 100) and the mean achilles tendon total rupture score was 95 ± 5.7 (range, 87 to 100).One patient with screwed suture anchors had backing out of two anchors along with deep infection, requiring surgical debridement and anchor removal.One other patient had a post-traumatic small wound dehiscence which responded to local wound care.The article describes the following procedure: extensile posterior approach to the ankle with detachment of the achilles tendon.The devices involved were: four double armed suture anchors (gii mitek with no.2 ethibond polyester sutures, depuy, westwood, ma) were placed in the calcaneal tuberosity and were used to reattach the achilles tendon to the calcaneus.Additional no.0 sutures were used to reinforce and flatten out the surrounding edges of the tendon to provide for smooth transition between the tendon and the heel.Complications mentioned in the article were: two of four suture anchors pulled out at 8 months.This was also complicated with infection (mmsa).This required incision and drainage, removal of those 2 suture anchors and 6 weeks of antibiotics.Post-traumatic superficial wound dehiscence at 4 weeks.Uneventful recovery on nonoperative management.

• Brand Name: UNKNOWN GII ANCHOR
• Type of Device: SOFT-TISSUE ANCHOR, NON-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 Key: 9218049
• MDR Text Key: 176347113
• Report Number: 1221934-2019-59142
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK GII ANCHOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR