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 No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date, the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Initial reporter phone number (b)(4).Udi: (b)(4).

Event Description

It was reported by the affiliate that they had some issue with those shaver blade.Some small particles of metal was coming from shaver blade when we started to use.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the event occurred during a knee athroscopy procedure.A new shaver blade device was used to complete the procedure without delay.There were no adverse consequences to the patient.The fragments were removed easily.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device [lot : m2002019], and no non-conformances were identified.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.

• 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
• MDR Report Key: 10638828
• MDR Text Key: 210210828
• Report Number: 1221934-2020-02893
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022229
• UDI-Public: 10886705022229
• Combination Product (y/n): N
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283429
• Device Catalogue Number: 283429
• Device Lot Number: M2002019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/08/2020; 12/18/2020
• Supplement Dates FDA Received: 10/09/2020; 12/18/2020
• Patient Sequence Number: 1