MAUDE Adverse Event Report: DEPUY MITEK FULL RADIUS CUTTER (LIGHT YELLOW) 3.5 MM; FMS BLADES & BURRS

Catalog Number 283305

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/05/2016

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).The lot expiration date is currently unavailable.

Event Description

Surgeon was using 283305 (oscillate) to shave some tissue inside the ankle joint, then when he switched to forward, he noticed some metal debris coming out from the shaver when in contact with the bone.It appears unusual.Additional information received on 9-14-2016: the metal shavings were sucked out with shaver suction (as much as possible).The delay was probably about 10 mins, total procedure time was 50 mins.

Manufacturer Narrative

The complaint device was not returned and no further information has been provided about the device.In 2012, mitek analyzed the safety impact of metal particulate being left in the patient¿s joint space.The analysis encompasses reported complaints, device failure mode and effects analyses (fmea¿s), labeling, bench testing, surgeon inputs and published clinical literature.In this study, the amount of particulate generated by mitek instruments was compared against particulate amounts reported in published literature.Mitek devices were found to generate significantly less than what was reported in published literature.The review found that metal particulate generated from mitek instruments were found to occur at low levels without clinical consequences.With regard to the referenced complaint the most probable cause of metal shavings is the blade making contact with another instrument within the joint.Mitek blades and burrs are designed in a way to prevent metal on metal contact.Specifically, the rotating shafts are lubricated with biocompatible grease that should prevent metal on metal contact for the duration of the surgery.On rare circumstances such as extended or aggressive use, the blades may generate a small amount of fine metal particulate that is easily flushed from the joint space.A batch record review has been conducted and the 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 mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.At this point in time, 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.(b)(4).

• Brand Name: FULL RADIUS CUTTER (LIGHT YELLOW) 3.5 MM
• Type of Device: FMS 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: 6001919
• MDR Text Key: 56536674
• Report Number: 1221934-2016-10417
• 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: 09/05/2016

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: 283305
• Device Lot Number: M1603042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2016
• Initial Date Manufacturer Received: 09/05/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other