MAUDE Adverse Event Report: DEPUY MITEK MITEK 5 MM AGGRESSIVE BLADE PLUS; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number 287519

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

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.No udi # exists for the specified product code.This product code was discontinued for sale in the us in november 2014.Device not yet returned.

Event Description

Diameter of this knife too large for this type of intervention and the end of the knife caused a reversible injury of the healthy cartilage of patient.Date of event is unknown.

Manufacturer Narrative

Mitek was informed on feb 8, 2017 that the complaint device is not being returned and therefore not available for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A dhr review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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: MITEK 5 MM AGGRESSIVE BLADE PLUS
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6212165
• MDR Text Key: 63477113
• Report Number: 1221934-2016-10570
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2016,12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 287519
• Device Lot Number: M1509023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2016
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other