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U.S. Department of Health and Human Services

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

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ORTHALIGN INC. KNEEALIGN 2 THREADED PIN Back to Search Results
Model Number 402395
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2019
Event Type  malfunction  
Manufacturer Narrative
An orthalign distributor reported that during a total knee arthroplasty pin drivers were used to remove small headed pins. A pin driver was used and the pin head snapped off. This pin head was stuck inside of the driver rendering it 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 pin in this case was 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
Head of the pin broke off when using the pin driver.
 
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Brand NameKNEEALIGN 2
Type of DeviceTHREADED PIN
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 Key8426670
MDR Text Key139056533
Report Number3007521480-2019-00008
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/23/2020
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 Number402395
Device Catalogue Number402395
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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