MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANT; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number UNK - IMPLANT

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

Patient Problem Joint Laxity (4526)

Event Type  Injury  

Manufacturer Narrative

(510k): this report is for an unknown implant.Part and lot number are unknown.Without the specific part number; the udi number, 510-k number and manufacturing site name are unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

This file is a review of the following journal article: carroll, k., et al (2013) approach to management of the patient with the multiligament-injured knee.The harvard orthopaedic journal, vol.15, pages 54-64 (usa).The study emphasizes on offering an algorithm for management of the patient with a multiligamentous injury to the knee.To describe the clinical and functional outcomes of a consecutive series of patients with multiligament knee injuries managed with this approach by a single surgeon and to present a novel surgical technique for the treatment of multiligamentous knee injuries.The patients evaluated on course of this study: 16 patients.The article describes the following procedure: surgical reconstruction of multiligament-injured knees.The device involved was: milagro interference screw.Complications described: complications included the need for a revision due to recurrent instability.This occurred in 1 (6%) patient.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This rep ab m to investigate or verify prior to the required reporting date.This report does no re required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned; the availability of the device is unknown, therefore unavailable for a physical evaluation.No additional information could be requested as the associate contact or patient details were available.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Since no lot number was provided, a manufacturing record evaluation or sterile load review could not be conducted.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: UNK - IMPLANT
• Type of Device: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11281736
• MDR Text Key: 233359704
• Report Number: 1221934-2021-00399
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANT
• Date Manufacturer Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention