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

Model Number 403007

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/28/2016

Event Type  Injury  

Manufacturer Narrative

Orthalign conducted a conference call with the reporting surgeon, dr.(b)(6), on 06/30/2016, regarding the reported issue.The following points were noted: dr.(b)(6) stated that the patient was a normal sized woman.There were no special circumstances or surgical complications.The patient had standard osteoarthritis, without dysplasia.Bone quality was normal.The orthalign jig was securely fixed during the procedure; dr.(b)(6) had two assistants helping him with the procedure; they removed the "jig" (pelvic base, bracket and probe) after navigating and impacting the cup placement.The jig was removed while they were putting in retractors and preparing the femur; the pins were also removed at this time, using a (b)(4) (b)(4) system 6 surgical drill; he suspects the pin broke while it was being removed.This was not noticed at the time; the pin tip was visible on the first x-ray of the patient's hip taken at the 6-week follow-up visit.After seeing the tip at the edge of the x-ray, dr.(b)(6) took a second x-ray to include the full hips.The 2nd x-ray showed the full pin section in the right ilium; the patient presented as asymptomatic and "doing great" at the 6 week follow-up visit; dr.(b)(4) explained the x-ray and retained pin to the patient.He made the patient aware of the metal in her body for potential mri procedures.He recommended leaving the pin in, since there were no symptoms or adverse reactions to it.The patient elected to leave the pin in and was "fine with it" and "accepting of the situation"; dr.(b)(6) also elected to do nothing additional due to the retained pin.He scheduled a routine 1-year follow-up with the patient, and intends to x-ray the pin location again at that time; dr.(b)(6) stated that he sees a drill bit, pin or similar fragment left in the bone of one-out-of-two hundred to one-out-one-hundred patients (from prior surgical procedures).Foreign object breakage and retention in a patient's bone is an existing occurrence in orthopedic surgery.He recently saw a patient who had been previously treated in (b)(6) and had a drill bit piece retained in his ilium.The patient was asymptomatic and "fine with it."; we informed dr.(b)(5) that the pin material was electropolished 17-4 ph h900 stainless steel, and that it is biocompatible, but not validated for long term implantation.17-4 stainless is a common, widely used material in orthopedic surgical instruments.Dr.(b)(6) noted that other retained objects (like the pin and drill bit fragments mentioned above) were in the same category, possibly of the same material; dr.(b)(6) stated that the risk from the retained pin is a potential foreign body reaction "just like with any implant." there is sometimes a risk of migration with retained objects in the body, but he thought there "limited odds" of that happening in this case, given its location in the ilium and the nature of the screw thread fixation; we enquired if dr.(b)(6) recommended or made any technique changes after this incident.He replied that he had discussed the incident and the importance of inspecting pins at the time of removal with his surgical assistants.The orthalign plus hipalign instrument sets (403007) were returned to orthalign for evaluation.No issues were discovered with any of the instruments in the sets.All included parts met specifications.The pins were not returned with the sets.They were most likely discarded by the hospital after use.So the pin involved in this incident was not available for further evaluation.The lot history, including inspection records and material certifications, for the pins supplied with the sets to the user were evaluated.No issues or discrepancies were discovered.

Event Description

A surgeon reported the tip of a fixation pin retained in the pelvis of a patient following a tha procedure navigated with the orthalign plus system.There was no detection of pin breakage or complications at the time of surgery.An x-ray during the patient's six week follow-up visit showed a pin section lodged in the right iliac wing.The patient did not have any complications or symptoms related to the retained pin section at the time of the follow-up visit.The surgeon and patient elected to leave the retained pin section in place.No adverse reactions or complications were expected.

• Brand Name: ORTHALIGN PLUS
• Type of Device: COMPUTER ASSISTED SURGERY SYSTEM, PRODUCT CODE: OLO
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia, ste 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 columbia, ste 500; aliso viejo CA 92656
• Manufacturer Contact: david vancelette ; 120 columbia, ste 500; aliso viejo, CA 92656 ; 9495259034
• MDR Report Key: 5832004
• MDR Text Key: 50715967
• Report Number: 3007521480-2016-00003
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 403007
• Device Catalogue Number: 403007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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: 65 YR
• Patient Weight: 64