MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL SHAVER HANDPIECE 2.0 WITH BUTTONS; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Model Number 283812

Device Problem Device Remains Activated (1525)

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

Event Date 11/22/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the sales rep that during a shoulder repair surgery on (b)(6) 2021, it was observed that the shaver handpiece 2.0 with buttons device turned on wide open without the buttons being touched.There were no adverse patient consequences nor surgical delay 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.Investigation summary : the complaint device was received at the r&d & manufacturing site and evaluated.It was reported that the shaver turned on wide open without the buttons being touched.Per service reports, this complaint can be confirmed.During the analysis of the device, it was deemed that the motor presented a failure; 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.This issue has been escalated to a capa.With the information provided, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device serial number (b)(6), and no non-conformances related to the reported complaint condition were identified.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.D9: the date device returned to manufacturer has been updated to reflect the correct information.

• Brand Name: SHAVER HANDPIECE 2.0 WITH BUTTONS
• Type of Device: LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 12931282
• MDR Text Key: 281748326
• Report Number: 1221934-2021-03585
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705030743
• UDI-Public: 10886705030743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

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: 283812
• Device Catalogue Number: 283812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/05/2021
• Supplement Dates Manufacturer Received: 12/15/2021
• Supplement Dates FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1