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

(b)(4). Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Subsequent follow-up with the customer, additional information was received. It was reported that the event occurred during knee arthroscopy surgical procedure. It was reported that there were 15 blades involved in the event with two that are missing. Therefore, this is report 1 of 15 for the same event. It was reported that there was a delay of five minutes. It was reported that there were no patient consequences or impact to the user or patient. It was reported that the surgery was completed by changing the blade. It was reported that there were metallic deposits at the start of the surgery. It was reported that an alternative product was readily available. It was reported that there was no surgical intervention planned (e. G. X-rays, additional/change in procedures, prescriptions, otc, revisions). It was reported that the fragments were easily removed without additional intervention by washing the joint. (b)(4).

Event Description

This is report 13 of 15 for the same event. It was reported by the affiliate in (b)(6) that during a knee arthroscopy surgical procedure, it was observed that 15 ultra aggressive plus 4. 0mm 5pk devices had metallic debris/deposits at the start of the surgery. As a result, there was a delay of five minutes as an alternative product was readily available to complete the procedure. It was reported that the surgery was completed by changing the blade. The fragments were easily removed without additional intervention by washing the joint. There were no patient consequences or impact to the user or patient. There was no surgical intervention planned (e. G. X-rays, additional/change in procedures, prescriptions, otc, revisions).

• 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: 9729730
• MDR Text Key: 200393008
• Report Number: 1221934-2020-00615
• 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: company representative,foreig

Reporter Occupation

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

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/19/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Initial