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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US REMOTE CONTROL(FMS VUE/NEXTRA) FOOT-SWITCH, ELECTRICAL

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DEPUY MITEK LLC US REMOTE CONTROL(FMS VUE/NEXTRA) FOOT-SWITCH, ELECTRICAL Back to Search Results
Model Number 283551
Device Problem Intermittent Continuity (1121)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/10/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Investigation summary: according to the information provided, it was reported that during a rotator cuff repair the remote controls failed. The complaint device was received and evaluated. Visual inspection was performed and there¿s no damage in the device. During testing performance, the remote control was connected in the pump and the buttons did not respond properly due to showed intermittence in their operation. The device was tested several times to ensure the improper functioning. The customer complaint can be confirmed. The possible root cause for the reported failure can be attributed to internal electrical deficiencies / defective components. However, this cannot be conclusive determined. 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. 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 sales rep via phone that during a rotator cuff repair the remote controls failed. The circulating nurse manually adjusted the pressure on the pump as needed to complete the procedure. No patient consequences, or surgical delay reported. The devices are available to be returned for evaluation.
 
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Brand NameREMOTE CONTROL(FMS VUE/NEXTRA)
Type of DeviceFOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10607220
MDR Text Key209254833
Report Number1221934-2020-02812
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 09/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283551
Device Catalogue Number283551
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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