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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACUMED LLC 8MM POLARUS® CAP SCREW ASSEMBLY INSTRUMENT, CAP SCREW

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ACUMED LLC 8MM POLARUS® CAP SCREW ASSEMBLY INSTRUMENT, CAP SCREW Back to Search Results
Model Number HR-0028-S
Device Problem Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2018
Event Type  malfunction  
Manufacturer Narrative
Returned product examined visually under magnification. First thread has been deformed and rolled back. This deformation is likely due to cross-threading of the parts combined with excessive torque. Cross-threading is more likely on shorter parts due to the difficulty in aligning the axes. Additional mdrs associated with this event: 3025141-2018-00332: nail.
 
Event Description
While attempting to attach the cap screw to the polarus plus humeral rod, it was noticed that there was no polyethylene insert in the cap screw. The insert was looked for and was not found. It is not known if the insert was left behind in the patient or if it was never present.
 
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Brand Name8MM POLARUS® CAP SCREW ASSEMBLY
Type of DeviceINSTRUMENT, CAP SCREW
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 lehman
5885 ne cornelius pass road
hillsboro, OR 97124
5032071387
MDR Report Key8099906
MDR Text Key128585609
Report Number3025141-2018-00331
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K013616
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 10/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2021
Device Model NumberHR-0028-S
Device Catalogue NumberHR-0028-S
Device Lot Number336851
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2014
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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