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.

• Brand Name: KNEEALIGN 2
• Type of Device: THREADED 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 Key: 8426670
• MDR Text Key: 139056533
• Report Number: 3007521480-2019-00008
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163379
• Number of Events Reported: 1
• 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 Received: 03/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 402395
• Device Catalogue Number: 402395
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/13/2019
• 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