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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED, LLC 12.0MM, MICRO ACUTRAK 2® BONE SCREW; SCREW, FIXATION, BONE

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ACUMED, LLC 12.0MM, MICRO ACUTRAK 2® BONE SCREW; SCREW, FIXATION, BONE Back to Search Results
Model Number AT2-C12-S
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2022
Event Type  Injury  
Manufacturer Narrative
Manufacturing and inspection records were reviewed, and no anomalies were found.The returned 12.0mm, micro acutrak 2® bone screw was examined visually under magnification.There appeared to be scratches on the screw head and white/tan material between the threads at the tip.Functional tests exhibited that both returned drivers can be inserted and removed from the screw by hand.Sticking of the drivers was confounded due to the twist in the hex tips.Due to unknown procedural conditions, no definitive conclusion on the cause of the incident can be made.
 
Event Description
It was reported that during the procedure when the surgeon removed the screwdriver from the screw after inserting the screw, the screw was pulled out from the bone due to the strong fixing force between the screw and the screwdriver.The screw was used for the talus.Because of the larger hole in the bone, the surgeon could no longer use the micro screws.Therefore, he switched to the mini screw.This report is related to report numbers 3025141-2022-00104 and 3025141-2022-00105 which are for the other devices involved in this event.
 
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Brand Name
12.0MM, 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
ellie wood
5885 ne cornelius pass road
hillsboro, OR 97124
5035209618
MDR Report Key14162198
MDR Text Key289680325
Report Number3025141-2022-00106
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberAT2-C12-S
Device Catalogue NumberAT2-C12-S
Device Lot Number478345
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2022
Initial Date Manufacturer Received 03/23/2022
Initial Date FDA Received04/20/2022
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient RaceAsian
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