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

Model Number	402395
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Head of the pin broke off when using the pin driver.
Additional Manufacturer Narrative
No product was returned for evaluation by orthalign and thus the initial report cannot be confirmed.Without the product orthalign was unable to perform a device history record review or a failure analysis.No further information was made available to orthalign and the investigation has been closed.

• Brand Name: KNEEALIGN 2
• Common Device Name: THREADED PIN
• Manufacturer (Section D): ORTHALIGN INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 8426670
• Report Number: 3007521480-2019-00008
• Device Sequence Number: 16686990
• Product Code: OLO
• UDI-Device Identifier: 00851977007178
• UDI-Public: 00851977007178
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K163379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 402395
• Device Catalogue Number: 402395
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2019
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/16/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention