MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL SHAVER HANDPIECE 2.0 WITH BUTTONS; ARTHROSCOPE

Catalog Number 283812

Device Problems Overheating of Device (1437); Noise, Audible (3273)

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

Event Type  malfunction  

Event Description

It was reported by the affiliate in sweden that during an unspecified procedure on an unknown date, the shaver handpiece 2.0 device sounded bad and became hot.Another like device was used to complete the procedure.There were no delays reported.There were no adverse patient consequences reported.No additional information was 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 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.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.H10 additional narrative: as of this date, the device has not been returned for evaluation.Therefore, the reported condition cannot be confirmed and/or duplicated.H4: the device manufacture date is currently unavailable.Udi: (b)(4).

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.Device was used for treatment, not diagnosis.H10 additional narrative: investigation summary : the complaint device was received at the r&d.The unit involved in this complaint has been received and per s&r technicians, these units fall under capa and escalation, therefore no service/wo will be performed.These units presented a failure in the motor; however, as the motor cannot be disassembled to perform a repair, the devices must be discarded.The front seal of the motor is allowing saline to enter the motor during use.This causes the handpiece to stop functioning.This fault affects the reliability of the handpiece but does not adversely impact patient safety.Manufacturing record evaluation (mre) is not needed since the device falls into capa that was opened due to the motor cannot be disassembled to perform a repair.The products (283712 & 283812) produced with the original design are not serviceable.The root cause is attributed to manufacturing involving a design change.There is a capa associated with this product code, most of the complaints received to-date are related to failed motors with evidence of water intrusion and manifested as malfunctioning or seized motors, therefore; the devices are under service discontinuation.This product issue is already being addressed by depuy quality system.Further investigation and assessment are covered under the capa in our quality system.Depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: SHAVER HANDPIECE 2.0 WITH BUTTONS
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 17919860
• MDR Text Key: 325489863
• Report Number: 1221934-2023-03701
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705030743
• UDI-Public: 10886705030743
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K041824
• 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
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283812
• Device Lot Number: M28AB2019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1