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

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.

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
• Type of Device: THREADED PIN
• Manufacturer (Section D): ORTHALIGN INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 8426670
• MDR Text Key: 139056533
• Report Number: 3007521480-2019-00008
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00851977007178
• UDI-Public: 00851977007178
• Combination Product (y/n): N
• PMA/PMN Number: K163379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 402395
• Device Catalogue Number: 402395
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 03/16/2019
• Supplement Dates Manufacturer Received: 02/13/2019
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention