MAUDE Adverse Event Report: DEPUY MITEK LLC US 8022 HAND PC TORNADO SHAVER -NS; LINE-POWERED ARTHROSCOPIC SHAVER SYSTEM

Catalog Number 288022

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and repaired at the service center.The complaint was confirmed.The following information was derived from the service report: "tornado": preventive replacement of o-rings performed.Motor does not turn: motor replaced.Protective conductor resistance out of tolerance - motor cable replaced.Defective o-rings replaced.Damaged parts of the drill mounting mechanism replaced.Unit cleaned.Functional test performed.Procedure completed.Safety test checklist enclosed.Electrical safety test completed.When the motor is seized, the device will not operate as intended therefore is a potential root cause for the reported failure.However, given the information provided we cannot discern a definitive root cause for the reported failure.The device is categorized under legacy manufacturing.A review of lot/batch history for each legacy fms product complaint is not recommended since legacy manufacturing no longer exists, and it is no longer possible to make process corrections or corrective actions.At this point, no corrective action is required and no further action is warranted.However, depuy synthes 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.Udi: (b)(4).

Event Description

It was reported by the affiliate that the device does not start.

• Brand Name: 8022 HAND PC TORNADO SHAVER -NS
• 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 ; 6103142063
• MDR Report Key: 8196310
• MDR Text Key: 131490413
• Report Number: 1221934-2018-55824
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705018345
• UDI-Public: 10886705018345
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2018

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 Catalogue Number: 288022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1