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

Catalog Number UNK GII ANCHOR

Device Problem Off-Label Use (1494)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown gii anchor.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr, manufacture date: 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: daisuke kawamura et al, 1998, ¿an experience of osteosynthesis using a mitek gii anchor for old avulsion fracture of the lateral malleolus of the ankle¿, the hokkaido journal of orthopedics and traumatology, vol.41, no.1, japan.The study emphasizes on clinical experience of osteosynthesis using a mitek gii anchor for old avulsion fracture of the lateral malleolus of the ankle.The patients evaluated on course of this study: total five subjects (four males and one female) with an avulsion fracture of the lateral malleolus of the ankle with mean surgical age was 19.6 years was enrolled for this study.All five cases involved old injuries that were one year or older, the mean postoperative monitoring period was 8.4 months (5 to 12 months), and the injury time was unknown.Subjects underwent for osteosynthesis based on four indication: pain during or after exercise, repeated varus sprain, impaired ability to play sports, and mobility of bone fragments with varus stress.The article describes the following procedure: intraarticular approach was adopted for this surgery.Mitek g ii anchor was inserted in bone fragments covered by scar tissue.In order to increase bone union, bone taken from the medial malleolus of the ankle was transplanted.Postoperative aftercare involved six-week lower leg casting, starting partial weight-bearing in two weeks postoperatively, and then allowed full weight-bearing in four weeks postoperatively.Postoperative examinations were conducted in averaging 8.4 months, assessing instability, pain, presence of bone union according to x-rays, and sports level.Instability was assessed by measuring and studying the talar tilt angle (tta), talar anterior displacement ratio (tadr) according to stress xrays.The devices involved were: unknown mitek gii anchor was used/mentioned for each patient in the literature article.Complications mentioned in the article were: in the one case no confirmed bone union was observed, from the review of the article it can be concluded that the use of mitek gii anchor described is a case of off-label use.The mitek gii anchor on-label use is soft tissue to bone fixation, whereas the article covers bone-to-bone fixation.

• 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 ; 5088808100
• MDR Report Key: 8749566
• MDR Text Key: 149680453
• Report Number: 1221934-2019-57498
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention