MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO TORNADO HP W HANDCONTROL; ACCESSORIES, ARTHROSCOPIC

Model Number 283512

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Alert date of event; deemed reportable.Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device does not turn due to jammed motor was confirmed.It was further found that the motor was not running smoothly and was corroded.The motor was also found to be too loud during operation.There was a short circuit in the motor cable.The resistance value of the keypad of the handcontrol set was out of specification and were drifting.As a result, the keypad assembly was not working properly.The motor, motor cable and the handcontrol set were replaced to correct the reported and identified failures.The device was cleaned, repaired and tested for functionality.Fluid ingress into the system and contact with the motor is responsible for the corrosion of the motor.Also the ingress would have damaged the motor cable would have resulted in the short circuit.The corroded motor has a tendency to stick and not turn, hence is responsible for the issue reported by the customer.However, given the information provided we cannot discern a definitive root cause for the defective keypad.A manufacturing record evaluation was performed for the finished device (serial number : (b)(4)), and no non-conformances were identified 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: a manufacturing record evaluation was performed for the finished device (serial number : (b)(4)), and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(4).As follows: it was reported that the micro tornado handpiece with hand controls needs service.It was discovered that the device does not turn due to jammed motor.There were no patient consequences or surgical delay reported.The procedure was completed using a replacement device.This is report 1 of 1 for (b)(4).

• Brand Name: MICRO TORNADO HP W HANDCONTROL
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8985119
• MDR Text Key: 183772397
• Report Number: 1221934-2019-58242
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705016938
• UDI-Public: (01)10886705016938
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K954465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2019

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 Model Number: 283512
• Device Catalogue Number: 283512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/10/2019
• 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: Unknown
• Patient Sequence Number: 1