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

Catalog Number UNK GII ANCHOR

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 product: 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: lefevre, n., et al (2007), rupture of the ischial origin of the hamstring muscles among athletes: a report of 9 cases of surgical repair, journal of sports traumatology, vol.24, pages 143-147 (france).The study emphasizes on presenting an experience on the management of a rare lesion and providing information on the results of operations on 9 athletes.The patients evaluated on course of this study: between 2002 and 2006, a total of 9 patients (all male), with an average age of 36.4 years (range 20 to 59 years), who underwent complete and proximal hamstring rupture were included in the study.There were 4 rugby accidents, 2 soccer, 1 fencing, 1 aikido and 1 household accident.All patients described the same symptoms associating a violent pain in the buttock (impression of stabbing) followed by weakness of the leg with support impossible.Clinical examination showed a large posterior hematoma and, on palpation, a vacuum under the ischial tuberosity.A simple leg splint immobilized the knee in flexion at 30° for 4 to 5 postoperative days, it was replaced by a custom-made hinged knee brace allowing free flexion of the knee, but an extension limited to 30°, it was worn for 45 days.Functional rehabilitation was started quickly by isometric work of the hamstring muscles for 6 weeks, relayed by active work.All patients were followed up regularly for the first 6 months.The article describes the following procedure: procedure for complete rupture of the hamstring at the proximal bone tendon junction by re-inserting the tendons into the bone with mitek gii anchors.The device involved was: mitek gii anchor.Complications mentioned in the article: 1 patient complained of discomfort at the ischium while siting on the hard plane.1 case of anchor migration.1 case of superficial burn of the scrotum (with iodized alcohol).

• 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: 9245442
• MDR Text Key: 206765400
• Report Number: 1221934-2019-59275
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• 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: 10/24/2019
• 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