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

Model Number	403185
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: COMPUTER ASSISTEED SURGEY SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; #500; aliso viejo CA 92656
• MDR Report Key: 7770470
• Report Number: 3007521480-2018-00002
• Device Sequence Number: 184894
• Product Code: OLO
• UDI-Device Identifier: 00858704006725
• UDI-Public: 00858704006725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162962
• 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,Followup
• Report Date (Section B): 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 08/10/2018
• 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: Other
• Patient Age: 67 YR
• Patient Weight: 60