• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC 16.0MM, MICRO ACUTRAK 2® BONE SCREW; SCREW, FIXATION, BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ACUMED LLC 16.0MM, MICRO ACUTRAK 2® BONE SCREW; SCREW, FIXATION, BONE Back to Search Results
Model Number AT2-C16-S
Device Problem Mechanical Jam (2983)
Patient Problem Bone Fracture(s) (1870)
Event Date 11/17/2021
Event Type  malfunction  
Event Description
While implanting a micro acutrak bone screw into the radial head, the driver tip became stuck in the screw head following insertion of the screw in the bone.When the driver was removed, the screw pulled out of the bone, refracturing the bone.
 
Manufacturer Narrative
The returned product was examined under magnification.The screw showed some minor signs of wear around the top face of the screw.Additionally, some of the screw threads showed areas where the anodization purple color had worn away and the remaining thread faces were silver and shiny.It is not possible to determine if these signs of wear were the result of implantation or from the screw pulling out of the bone.Additional mdrs associated with this event: 3025141-2021-00160: driver.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
16.0MM, MICRO ACUTRAK 2® BONE SCREW
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer (Section G)
ACUMED LLC
5885 ne cornelius pass road
hillsboro OR 97124
Manufacturer Contact
micki anderson
5885 ne cornelius pass road
hillsboro, OR 97124
MDR Report Key13124499
MDR Text Key285393512
Report Number3025141-2021-00161
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K944330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/09/2021
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 NumberAT2-C16-S
Device Catalogue NumberAT2-C16-S
Device Lot Number500002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2021
Initial Date Manufacturer Received 12/09/2021
Initial Date FDA Received12/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient EthnicityNon Hispanic
Patient RaceAsian
-
-