MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS; COMPUTER ASSISTEED SURGEY SYSTEM

Model Number 403185

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/07/2018

Event Type  Injury  

Manufacturer Narrative

The retained pin fragment was not removed from the patient.The partial fragment, which was not implanted, was returned.Orthalign investigated the partial fragment.The lot number of the part could not be read due to excessive wear on the surface of the pin.A visual review of the fragment indicates helical scalloping on the diameter of the pin.The diameter was measured at the driving end of the pin at several locations and was confirmed to be within specification.All other critical dimensions were unable to be measured due to the return of a partial fragment.The pin (part number (b)(4) is a reusable instrument that is intended to be used with the orthalign plus system.Within the instructions for use for the orthalign plus system there is a warning with an instruction for the user to inspect each instrument thoroughly prior to use for any wear or damage.Users are instructed to replace damaged or worn instruments before next use as the use of damaged instruments may compromise the surgical outcome.The investigation has not identified any anomalies in the returned pin fragment.The customer reported that there was no patient intervention and no planned intervention.This report is being filed in an abundance of caution due to the potential risks associated with retained pin fragments.

Event Description

During a procedure of a navigated tha case, performed with orthalign plus navigation, a fixation pin broke during its attempted removal.The pin had been used to fixate the pelvic base during the and broke near the surface of the iliac crest.Upon attempted removal from the patient the pin fragmented in two.The proximal fragment was removed and has been returned to orthalign for investigation.The distal portion of the pin remains in the patients iliac wing.

• Brand Name: ORTHALIGN PLUS
• Type of Device: COMPUTER ASSISTEED SURGEY SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; #500; aliso viejo CA 92656
• Manufacturer Contact: katy nennig ; 120 columbia #500; aliso viejo, CA 92656 ; 9202546370
• MDR Report Key: 7770470
• MDR Text Key: 116700651
• Report Number: 3007521480-2018-00002
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00858704006725
• UDI-Public: 00858704006725
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 403185
• Device Catalogue Number: 403185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Date Manufacturer Received: 07/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 60