MAUDE Adverse Event Report: DEPUY MITEK LLC US BARREL TORNADO BURR 5.5MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283889

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

It was reported by the customer in (b)(6) that the barrel tornado burr 5.5mm blade device did not fit well with the handpiece device.There was no procedure nor patient involvement reported.No additional information was provided.

Manufacturer Narrative

Udi: (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.

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: devices reported in this complaint were not received for evaluation, however; other devices reported under other customer complaints for the issue ¿cutter cannot snap onto the micro tornado shaver¿ were received and analyzed.A manufacturing record evaluation was performed for the finished device lot number: m2106005, and no non conformances were identified.The investigation was divided into two stages, 1st stage consisted in complaint burr visual inspection and functional test at the product analysis lab, the result for this test indicated that the devices could not be assembled into micro tornado handpiece (p/n 283512).Due to these results, the burrs were then measured, and it was identified that 2 burr features of the outer blade hub were over the upper limit.Devices were sent to r&d lab to continue with the investigation.The part underwent dimensional inspection, where it was confirmed that 2 burr features were oversized (12.575mm feature and 15.72mm feature).Manufacturing was notified about the condition and a nonconformance record was created to continue the investigation, root cause determination and mitigation of the issue.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.Device history lot: a manufacturing record evaluation was performed for the finished device lot number: m2106005, and no non conformances were identified.The device manufacture date was unknown in the initial report and has been updated accordingly.

• Brand Name: BARREL TORNADO BURR 5.5MM 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12931398
• MDR Text Key: 281754100
• Report Number: 1221934-2021-03596
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022106
• UDI-Public: 10886705022106
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283889
• Device Catalogue Number: 283889
• Device Lot Number: M2106005
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1