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

Catalog Number 288022

Device Problem Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported by the affiliate in (b)(6) that the tornado shaver handpiece did not sniff.The issue was identified intra-op.There was user involvement.The outcome of the event and patient/user involvement is unknown.The case was completed using a replacement device.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.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 at service center and evaluated.The complaint was not confirmed.However,further defects have been verified and remedied using the measures as per the service report.Since the reported condition was not confirmed the root cause for the reported failure is undetermined."tornado": preventive replacement of o-rings performed, motor does not turn: motor replaced, defective o-rings replaced, unit cleaned, functional test performed, functional test completed, safety test checklist enclosed, electrical safety test completed, hipot test completed.The service history has been reviewed in lieu of the device history record for this device since it was previously serviced.The device was last serviced on 09/08/2018 and passed all functional testing before being returned to the customer.No further investigation is required.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).

• 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
• MDR Report Key: 8302275
• MDR Text Key: 134908835
• Report Number: 1221934-2019-56326
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705018345
• UDI-Public: 10886705018345
• Combination Product (y/n): N
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• 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: 01/06/2019
• Date Manufacturer Received: 01/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1