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

Catalog Number 288022

Device Problems Defective Component (2292); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).(b)(6).Investigation summary: the device was received at the service center and evaluated.The defect reported by the customer has been verified and repaired.The following repair activities were performed: as per the service report following spare parts were replaced.Motor was replaced.Cable was replaced.Motor -o ring was replaced.Locking system was replaced.Kynar sheath was replaced.The root cause of the reported issue is not determined.A review of the device history record indicated that this lot of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point in time, 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.

Event Description

It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that tornado hand piece device did not work that it needed to be serviced.During in-house engineering evaluation, it was determined that the locking system on the device was damaged/defective.The procedure was completed as intended.There was no potential harm was reported and no delays.It was not reported if a spare device was available for use to complete the surgery.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 8196203
• MDR Text Key: 131493364
• Report Number: 1221934-2018-55823
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705018345
• UDI-Public: 10886705018345
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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
• Type of Report: Initial
• Report Date: 12/20/2018

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: 12/03/2018
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 12/26/2018
• Date Device Manufactured: 03/26/2014
• 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