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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC TOWER WRIST JOINT LOCKING ROSETTE KNOB APPARATUS, TRACTION, NON-POWERED

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ACUMED LLC TOWER WRIST JOINT LOCKING ROSETTE KNOB APPARATUS, TRACTION, NON-POWERED Back to Search Results
Model Number 10150143
Device Problem Degraded (1153)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/10/2019
Event Type  Injury  
Manufacturer Narrative
Returned product examined visually under magnification. All threaded features were inspected and found to be in good condition. Welds connecting the arm sleeves to the locking joint have cracked. Additional mdrs associated with this event: 3025141-2019-00098: rosette knob 2; 3025141-2019-00099: tower wrist joint; 3025141-2019-00100: tower upper arc.
 
Event Description
During surgery on the patient's arm, it was supported by the arc wrist tower. During the surgery, the surgeon found tiny metal flakes in the wound. The flakes were coming from the arc wrist tower. All of the metal flakes were not successfully removed from the wound, as some were sticking to the synovium even when washed thoroughly. There was a delay in surgery as a result of this situation.
 
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Brand NameTOWER WRIST JOINT LOCKING ROSETTE KNOB
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
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
8886279957
MDR Report Key8301469
MDR Text Key134894104
Report Number3025141-2019-00097
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
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 01/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10150143
Device Catalogue Number10150143
Device Lot Number429434
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/15/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/04/2019 Patient Sequence Number: 1
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