MAUDE Adverse Event Report: DEPUY MITEK 4 MM ULTRA AGGRESSIVE PLUS; FMS BLADES & BURRS

Catalog Number 283429

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

The complaint device was not returned and no further information has been provided about the device.However, past investigations have shown that a bend in either outer or inner blade would increase friction between the inner and outer shaft which could lead to metal shavings as reported.This cannot be confirmed as the devices were not returned.A dhr 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).

Event Description

The shaver blade caused a considerably amount of metal flaking after approximately 20-30 seconds of use.Additional information received via email from the affiliate on 2-1-2017 type of procedure was knee arthroscopy with torn meniscal debridement the metal shavings were removed to almost all extent! another new shaverblade of same code and lot number was used to complete the procedure additional information received via email from the affiliate on 2-16-2017 we have received information from the customer, that the product will not be returned.

• Brand Name: 4 MM ULTRA AGGRESSIVE PLUS
• 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: 6363434
• MDR Text Key: 68465510
• Report Number: 1221934-2017-10074
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 02/01/2017

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: 09/30/2021
• Device Catalogue Number: 283429
• Device Lot Number: M1610039
• 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: 02/01/2017
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other