MAUDE Adverse Event Report: DEPUY MITEK MINI ROUND BURR SHAVER BLADES NEXTRA 3.0MM; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number 283255

Device Problem Metal Shedding Debris (1804)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/12/2017

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.(b)(4).

Event Description

The affiliate reported via email enormous metal abrasion.Additional information received via email from the affiliate on 9-26-2017.Location of the substance on the device was upper ankle joint.Metal splitters with color from the back part of the burr (black blue).The foreign substance was retrieved with flush and shaving from the full radius blade.Some particles remain in the patient yes, the little metal splitters.The failure did not result in surgical delay of greater than 30 minutes or an inability to complete the procedure as intended.The procedure was completed by shaving with another blade (full radius blade).We have no other small burr in our portfolio.Surgical intervention is not planned yet.Patient impact is metal splitters in the ankle.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was received and evaluated.Visual inspection under magnification reveals that there are blue flakes of what appears to be the material that the hub is made from in the inner section of the burr and on the distal tip.The device was reviewed with the quality engineer and the design engineer.A possible root cause is that the blue material could potentially be flash material from the molding process for the manufacture of the hub.It is unknown how the material ended up on the distal end of the burr.When the burr is inserted into a hand piece and activated the suction is from the distal end through the hub.So, it is unknown based on the information provided how the blue material would travel in the opposite direction of the suction through the hand piece.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 evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed two other dissimilar complaints for this lot of devices that were released to distribution.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.Udi: (b)(4).

• Brand Name: MINI ROUND BURR SHAVER BLADES NEXTRA 3.0MM
• 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: 6939762
• MDR Text Key: 89234744
• Report Number: 1221934-2017-10565
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 283255
• Device Lot Number: M1603014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2017
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 10/11/2017
• Supplement Dates FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other