MAUDE Adverse Event Report: DEPUY MITEK LLC US 8022 HANDPC TORNADO SHAVER LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Model Number 288022

Device Problem Material Frayed (1262)

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

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4). Investigation summary: the complaint device was received at the service center and evaluated. It was reported that the cable is cut. Per service reports, this complaint can be confirmed. During the service evaluation the following defects were identified: cable sheath cut. Engine in poor condition (corroded motor). The motor and cable were replaced to resolve the issues. After repair, the device was found to be working according to the specifications. The faulty parts was identified as the root cause for the device failure during the service evaluation. 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. 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.

Event Description

It was reported by the customer in (b)(6) that during an unknown surgery on (b)(6) 2021, it was observed that the cable on the handpc tornado shaver device was cut. During in-house engineering evaluation, it was determined that the motor was corroded on the device. There were no adverse patient consequences nor surgical delay reported. No additional information was provided.

• Brand Name: 8022 HANDPC TORNADO SHAVER
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12253871
• MDR Text Key: 264338078
• Report Number: 1221934-2021-02341
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 288022
• Device Catalogue Number: 288022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown