MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS TORNADO MICRO HANDPIECE WITH BUTTONS; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Model Number 283512

Device Problems Overheating of Device (1437); Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 01/04/2023

Event Type  Injury  

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.Additional narrative: udi: (b)(4).The device manufacture date is currently unavailable.Investigation summary the complaint device was received at the service center and evaluated.During the service evaluation, no defects were identified.Hence, this complaint cannot be confirmed.The device was found to be working according to the specifications.As part of depuy mitek¿s quality process all devices are manufactured, inspected, and released to approved specifications.Since the reported condition is not confirmed and no defects were identified, the root cause for the reported failure cannot be determined.The event described could not be confirmed as the device was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the service evaluation.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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 review manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.

Event Description

It was reported by the distributor in brazil that during an anterior cruciate ligament reconstruction with meniscal repair procedure of the right knee on (b)(6) 2023, it was observed that the fms tornado micro handpiece with buttons device heated up.According to the report, the surgery started with an open procedure for removing the graft which lasted approximately 10 minutes.It was reported that after this moment, the arthroscopic procedure began.It was reported that when starting to use the shaver handpiece, it was noticed that it was very hot, to the point of being impossible to hold it.It was reported that the instrument was changed but they kept the same opme materials (shaver blade) without intercurrences.It was reported that the surgery went well until the end.It was reported that in the final moments of the surgery, the team observed that there were two small holes in the surgical field right in the middle of the table, which corresponded to the place where the shaver handpiece was.It was reported that at the end of the procedure, the nursing assistant drew attention to two small lesions, approximately 1.5 cm in diameter, on the patient's left leg with a hyperemic halo and a central area with the appearance of a ¿callus¿.It was reported that the team observed the injury and thought that it was not compatible with an acute injury (due to the aspect like a "callus") but we observed the injury anyway and stayed with them in the outpatient clinic.It was reported that upon returning to the outpatient clinic, with the lesion already in progression, the team observed that it was indeed a thermal lesion that occurred at the time of surgery, caused by the vertical handpiece with a defect and overheating.It was reported that the team informed the patient of what happened, remove any doubts and refer them to the stomatherapy outpatient clinic of this service.We also guide the weekly return and leave our it was reported that the patient was understanding and calm about the problem.The status of the patient was unknown.No additional information was provided.

• Brand Name: FMS TORNADO MICRO HANDPIECE WITH BUTTONS
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• 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: 16413646
• MDR Text Key: 309949515
• Report Number: 1221934-2023-00841
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: 10886705016938
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283512
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention