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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. DARCO TI LOCK PLATE, FIXATION, BONE
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WRIGHT MEDICAL TECHNOLOGY, INC. DARCO TI LOCK PLATE, FIXATION, BONE Back to Search Results
Model Number DCS2825016
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/15/2018
Event Type  malfunction  
Manufacturer Narrative
Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
 
Event Description
Allegedly, two 16mm locking screws were locked but other two 16mm locking screws would not lock onto the plate. The surgeon tried to insert a 18mm locking screw but it would not be locked. So the surgeon removed the locking screws and plate and used back up devices. Surgery time extended 40 minutes. No patient complications were reported.
 
Manufacturer Narrative
Visual examination of the part did not show any overall excessive gross deformation. However, there did appear to be some slight wear to the head threads and driving feature of the screw, most likely due to the attempted insertion.
 
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Brand NameDARCO TI LOCK
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
MDR Report Key7439819
MDR Text Key105919825
Report Number1043534-2018-00027
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K061808
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberDCS2825016
Device Lot Number1598012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2018
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/22/2018
Event Location Hospital
Date Manufacturer Received03/22/2018
Is This a Reprocessed and Reused Single-Use Device?

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