MAUDE Adverse Event Report: DEPUY MITEK 5.0 MM BARREL BURR PLUS; MITEK BLADES & BURRS

Catalog Number 283869

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot expiration date is currently unavailable.

Event Description

Small tiny bit of metal was ripped away from the burr event date: unknown.Photos available, will send once we get the official ref nr.Additional information received via email from the affiliate on (b)(6) 2016 type of procedure was mitek surgery, but what exactly the surgery was is unknown all the metal shavings were removed, but not sure what was used to remove them delay of 5 minutes.

Manufacturer Narrative

The complaint device was received and evaluated.Visual observation under magnification of the complaint device reveals that the corner of the distal end of the outer shaft has a small piece of the corner missing.Also there is marking on the inside of the sleeve which indicates that a strong lateral force was placed on the burr causing it to rub against the inner sleeve.This caused excessive friction and indicates that the device might have hit a hard surface, which could lead to metal shavings as reported.The doctor and the affiliate were contacted that reported this complaint and they indicated that the device may have gotten stuck between some bones during the operation.This complaint can be confirmed.A dhr review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of 40 devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.However, 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.Udi: (b)(4).

• Brand Name: 5.0 MM BARREL BURR PLUS
• Type of Device: MITEK BLADES & BURRS
• 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: 6119275
• MDR Text Key: 60655891
• Report Number: 1221934-2016-10499
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 283869
• Device Lot Number: M1605038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2016
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1