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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US 8022 HANDPC TORNADO SHAVER INE-POWERED ARTHROSCOPIC SHAVER SYSTEM Back to Search Results
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.
 
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Brand Name8022 HANDPC TORNADO SHAVER
Type of DeviceINE-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 Key13089708
MDR Text Key285433395
Report Number1221934-2021-03837
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
Number of Events Reported1
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 Received12/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number288022
Device Catalogue Number288022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2021
Date Manufacturer Received12/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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