MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS; COMPUTER ASSISTED SURGERY SYSTEM

Model Number 403185

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

The retained pin fragment was not removed from the patient.The other fragment was discarded and not returned.No further investigation was possible on this part, but the device history records and samples from the same lot of pins were reviewed.No issues or discrepancies were found in the manufacturing records or samples from the lot.(p/n: 403185, l/n: 16012101dm).Note: the navigation system name is orthalign plus.The pin part number 403185 is part of the reusable instrument set in the system.Device not returned.

Event Description

A stainless steel pin used to mount instrumentation to the patient during a total hip arthroplasty procedure broke during a removal attempt at the end of the procedure.The pin broke off flush with the bone in the patient's iliac crest.The top part of the pin was removed from the patient.The distal part of the pin remained in the patient's bone.No additional surgical steps or procedures were conducted as a result of this incident.No additional complications or effects on the patient were reported.The surgeon elected to leave the pin fragment in the bone and to monitor patient condition during follow-up visits.

• Brand Name: ORTHALIGN PLUS
• Type of Device: COMPUTER ASSISTED SURGERY SYSTEM
• 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: david vancelette ; 120 columbia, suite 500; aliso viejo, CA 92656 ; 9495259034
• MDR Report Key: 6514875
• MDR Text Key: 73451627
• Report Number: 3007521480-2017-00002
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00858704006725
• UDI-Public: 00858704006725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician Assistant
• Device Model Number: 403185
• Device Catalogue Number: 403185
• Device Lot Number: 16012101DM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 61