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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC 3.0MM X 145MM FIBULA ROD ROD, FIXATION, INTRAMEDULLARY

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ACUMED LLC 3.0MM X 145MM FIBULA ROD ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Model Number 40-0027-S
Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Event Description
A surgeon was preparing to implant a fibula rod into a patient, by preparing the canal. The desired sterile implant product was selected and the box was opened. The box was empty. The surgeon prepared a longer canal and implanted a longer rod. There was 40 minute delay in surgery as a result of the empty box.
 
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Brand Name3.0MM X 145MM FIBULA ROD
Type of DeviceROD, FIXATION, INTRAMEDULLARY
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 Key11630872
MDR Text Key249996630
Report Number3025141-2021-00029
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K951673
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 03/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number40-0027-S
Device Catalogue Number40-0027-S
Device Lot Number495981
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2020
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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