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

Model Number 288022

Device Problem Mechanical Jam (2983)

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

Event Date 01/01/2021

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 doesn¿t turn ¿ jammed motor. Per service reports, this complaint can be confirmed. During the service evaluation the following defects were identified: the motor sticks and is rusty, the cable resistance is out of tolerance, functional : locking mechanism does, not function. The defective motor cable, defective motor, and damaged parts of the drill mounting mechanism were replaced to resolve the issues. After repair, the device was found to be working according to the specifications. The faulty parts were 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 with 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. Device history lot: 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 customer in (b)(6) that during an unspecified surgical procedure, on an unknown date, it was observed that the 8022 handpc tornado shaver device did not turn - jammed motor. During an in-house engineering evaluation of a photo provided by the customer, it was determined that the anchor was deformed, and still attached to the inserter via the tensioned suture. Another like device was used to complete the procedure. There were no adverse patient consequences nor surgical delay reported. No additional information was provided.

• Brand Name: 8022 HANDPC TORNADO SHAVER
• Type of Device: INE-POWERED ARTHROSCOPIC SHAVER SYSTEM
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 13089708
• MDR Text Key: 285433395
• Report Number: 1221934-2021-03837
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign

Reporter Occupation

• Type of Report: Initial

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/27/2021
• 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: 12/02/2021
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial