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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC 3.0MM X 230MM ULNA ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES: ROD

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ACUMED LLC 3.0MM X 230MM ULNA ROD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES: ROD Back to Search Results
Model Number UL-3023-S
Device Problem Difficult to Remove (1528)
Patient Problem Insufficient Information (4580)
Event Date 12/17/2020
Event Type  malfunction  
Manufacturer Narrative
The returned 3. 0mm ulna nail, im rod targeting base, and im rod locking bolt were visually and functionally examined. The three products were returned together in a single assembly. The locking bolt was able to disengage from the ulna nail when un-screwed from the assembly but couldn't not disengage from the targeting base. The locking boot can spin/turn within the targeting base but will not retract, likely due to thread stripping of the locking bolt but this cannot be seen without destroying the targeting base. Scratches were present on both the targeting base and locking bolt, likely from the multiple removal attempts indicated. The interfacing surfaces of the ulna nail and targeting base were smooth upon examination. Additional mdrs associated with this event. 3025141-2021-00004: targeting base. 3025141-2021-00005: locking bolt.
 
Event Description
During removal of an ulna rod and screws (removal for unknown reasons), the screws came out with no issues but the surgeon had difficulties removing the rod. Using two of the components of the targeting guide to help with removal, they were finally able to remove the nail after a 45 minute delay in surgery and use of a competitor's nail removal process. Once removed, the targeting guide components were cold welded to the nail and could not be separated. They are no longer usable.
 
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Brand Name3.0MM X 230MM ULNA ROD
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES: ROD
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 Key11219028
MDR Text Key230091136
Report Number3025141-2021-00003
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K951673
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 12/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUL-3023-S
Device Catalogue NumberUL-3023-S
Device Lot Number365172
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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