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

Model Number	403189
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2019
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.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 or Problem Description
It was reported that both pin drivers had the head of the small headed pins snap off and get stuck.

• Brand Name: KNEEALIGN 2
• Common Device Name: PIN DRIVER
• Manufacturer (Section D): ORTHALIGN INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 8426672
• Report Number: 3007521480-2019-00007
• Device Sequence Number: 11211435
• Product Code: OLO
• UDI-Device Identifier: 00858704006435
• UDI-Public: 00858704006435
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K163379
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2019

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: 403189
• Device Catalogue Number: 403189
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 03/16/2019
• 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