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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN INC. KNEEALIGN 2 PIN DRIVER

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ORTHALIGN INC. KNEEALIGN 2 PIN DRIVER Back to Search Results
Model Number 403189
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/05/2019
Event Type  malfunction  
Manufacturer Narrative
An orthalign distributor reported that during a total knee arthroplasty pin drivers were used to remove small headed pins. Two pin drivers were used, and both snapped the heads of the pins off. These pin heads were stuck inside of the drivers rendering them useless. With an abundance of caution this report is being filed with the understand of the potential patient harm that could result with pins breaking. The pins in this case were removed and no patient injury was caused by this instrument malfunction. No product return is expected as orthalign was informed they were discarded post-surgery. An investigation is still pending based on internal reports and device history files. Once findings are available a follow up report will be filed.
 
Event Description
It was reported that both pin drivers had the head of the small headed pins snap off and get stuck.
 
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Brand NameKNEEALIGN 2
Type of DevicePIN DRIVER
Manufacturer (Section D)
ORTHALIGN INC.
120 columbia
suite 500
aliso viejo CA 92656
Manufacturer Contact
katy nennig
120 columbia
suite 500
aliso viejo, CA 92656
9202546370
MDR Report Key8426672
MDR Text Key139056627
Report Number3007521480-2019-00007
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163379
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 03/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number403189
Device Catalogue Number403189
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/16/2019 Patient Sequence Number: 1
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