MAUDE Adverse Event Report: DEPUY MITEK TORNADO MICRO HANDPIECE WITH BUTTONS; ARTHROSCOPIC SHAVER HANDPIECE

Catalog Number 283512

Device Problem Self-Activation or Keying (1557)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/05/2017

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device was returned to the service center for evaluation and repair.The defect reported by the customer has been verified and repaired.On inspecting the device, further deficiencies were found to be impairing device function.Performed mechanical upgrade, calibrated unit, replaced defective motor, replaced defective motor cable, replaced faulty keypad, replaced keyboard pcb, cleaned unit, preformed functional test, completed hipot test, and completed electrical safety test.Review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the records reviewed.Review of the depuy synthes mitek complaints system revealed one other dissimilar complaint for this serialized device.At this 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 to monitor the extent to which this complaint is observed in the field.(b)(4).

Event Description

Repair of unit: unit is defective.The device switches itself on/off.Description of failure: no other information available.Device error message: no other information available.When was the problem discovered?: pre-operatively.Surgical delay?: none.Per additional information received from the affiliate field service engineer on 9-18-2017: the event occured on (b)(6) 2017.The issue was detected before surgery and there was no patient impact.A replacement device was provided to the customer.

• Brand Name: TORNADO MICRO HANDPIECE WITH BUTTONS
• Type of Device: ARTHROSCOPIC SHAVER HANDPIECE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6886277
• MDR Text Key: 87654616
• Report Number: 1221934-2017-10523
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: LO
• 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: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: No
• Device Age: 45 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/10/2017
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1