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 Break (1069)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

The complaint device was received and evaluated. Visual inspection revealed the round burr and the blade is cold welded together. According to the ifu, the blade or burr shoudn't have been used without irrigation fluid or the blade may seized and eventually result in metal shaving. This failure can be attributed to user technique. 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 similar 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). Associated medwatch:1221934-2017-10590.

Event Description

The affiliate reported via email burr 283255 remained in the shaver and did not turn. A second burr also remained stuck in the shaver without any function. The procedure was completed with same like product. Additional information received via email from the affiliate on 9-19-2017. The blades were used in sterile water as normal in an arthroscopy. The issue was detected during the first turns from the blade. There was a resulting surgical delay of 15 minutes the procedure was completed by using an blade instead the defect burr. The original micro tornado (283512)hand piece was used. Patient impact was metal in the joint. Additional information received via email from the affiliate on 9-25-2017. No they couldn't be removed. It was a huge amount of shavings in many little pieces and the color was blue.

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 burr 283255 remained in the shaver and did not turn. A second burr also remained stuck in the shaver without any function. The procedure was completed with same like product. Additional information received via email from the affiliate on 9-19-2017: the blades were used in sterile water as normal in an arthroscopy. The issue was detected during the first turns from the blade. There was a resulting surgical delay of 15 minutes. The procedure was completed by using an blade instead the defect burr. The original micro tornado (283512)hand piece was used. Patient impact was metal in the joint. Additional information received via email from the affiliate on 9-25-2017. No they couldn¿t be removed. It was a huge amount of shavings in many little pieces and the color was blue.

• 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: 6944747
• MDR Text Key: 229298157
• Report Number: 1221934-2017-10586
• 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

• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 10/12/2017 Patient Sequence Number: 1