MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS; HIP REGISTRATION PROBE

Model Number	403305
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Possible system accuracy issue: incorrect probe scale value.It was reported by a distributor that during operation of the device, the probe scale value showed one while at zero position.The phenomenon occurred with combination of the probe scale and the reference sensor.This was a non-clinical incident (phenomenon did not occur during a surgical procedure).
Additional Manufacturer Narrative
At this time, the device in question has not been returned for evaluation.If the device is received, an investigation will be performed, and a followup report will be filed detailing the findings.With an abundance of caution this report is being filed with the understanding of the patient harm that could be caused by inaccurate measurement.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation.The investigation performed by the orthalign engineer was able to replicate the reported event.The returned registration probe was tested with the returned rs5 and was not able to acquire the "0" position.The returned registration probe was then tested with a known good rs5 and was able to acquire the "0" position.The returned rs5 was then tested with a known good registration probe and was able to acquire the "0" position.The mating combination of the returned registration probe and returned rs5 was the only failure.From inspection, both returned parts had no other identifiable defects.A root cause was not conclusively established, but it is suspected to be damage to the parts from being dropped or mishandled.A full evaluation summary is attached.Orthalign will continue to monitor this issue and take action when alert limits are exceeded.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: HIP REGISTRATION PROBE
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer Contact: karyl haskell ; 120 columbia; suite 500; aliso viejo, CA 92656
• MDR Report Key: 16820859
• Report Number: 3007521480-2023-00006
• Device Sequence Number: 6858579
• Product Code: OLO
• UDI-Device Identifier: 00851977007710
• UDI-Public: 00851977007710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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 Model Number: 403305
• Device Catalogue Number: 403305
• Device Lot Number: 19101401Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown