MAUDE Adverse Event Report: DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 4.0MM 5PK ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283429

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4).

Event Description

It was reported by the affiliate via complaint submission tool that during an unknown procedure the ultra aggressive plus 4. 0mm 5pk had metallic debris. No patient consequence was reported, however there was a 5 minutes surgical delay. No additional information was provided. Additional information provided by the affiliate reported 15 blades were involved in this complaint and the event occurred when the shaver was turned on at the beginning of a knee arthroscopic surgery. There were no known user or patient impacts due to the metallic shavings and the case was completed with a new blade. The reporter also stated the fragments were easily removed by washing the joint and additional surgical intervention is not required.

• Brand Name: ULTRA AGGRESSIVE PLUS 4.0MM 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9741986
• MDR Text Key: 192155891
• Report Number: 1221934-2020-00650
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/23/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 283429
• Device Catalogue Number: 283429
• Device Lot Number: M1905040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial