MAUDE Adverse Event Report: DEPUY MITEK LLC US 4 MM ROUND TORNADO BURR PLUS; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Model Number 283479

Device Problems Mechanical Problem (1384); Device Damaged Prior to Use (2284)

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

Event Date 10/12/2022

Event Type  malfunction  

Event Description

It was reported by a healthcare professional in china that during a rotator cuff repair procedure on (b)(6) 2022, it was observed that the 4 mm round tornado burr plus device was stuck upon opening its package.During in-house engineering evaluation of the video provided by the customer, it was determined that the burr appeared to be jammed and not able to rotate.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.

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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.Udi: (b)(4).Investigation summary: the complaint device is not being returned, it was discarded, therefore unavailable for a physical evaluation.However, a video of the device was provided.According with the visual inspection of the video, the burr appears to be jammed and not able to rotate; therefore, this complaint can be confirmed.The video does not provide enough evidence to determine root cause.Without physical evaluation, we cannot determine a root cause for the issue experienced by the customer.There were no details provided of the procedure and the speed used.There are controls in place where the shaver blade assembly, sleeve placement, the inner greaser and the shaver blade tray seal are checked, this test guaranties that the inner and outer have been properly assembled and is functional; this information correspond to a process control, and it is the appropriate document to use to guarantee that this issue can¿t have happened during manufacturing process.As per ifu, excessive side loading may result in blade wear and degradation, as well as clogging and/or seizing.Adequate suction is recommended to minimize clogging, reduce build-up of excised material in the joint, and reduce wear and degradation of the device.Or optimal soft tissue resection, run blade in oscillation mode.For bone cutting, run in forward or reverse.A manufacturing record evaluation was performed for the finished device m2106032, and no non-conformance 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: 4 MM ROUND TORNADO BURR PLUS
• 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 LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15916544
• MDR Text Key: 307999301
• Report Number: 1221934-2022-03833
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 20886705025432
• UDI-Public: 10886705025435
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283479
• Device Catalogue Number: 283479
• Device Lot Number: M2106032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2021
• 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