MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MM X 127MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSD01008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	09/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).
Event or Problem Description
It was reported that, after a navio assisted journey ii surgery was performed on (b)(6)-2021, the patient fell and a supracondylar fracture of the femur occurred at the navio bone pin 4.0mm x 127mm insertion point.A revision surgery will be performed on (b)(6)2021 to treat this adverse event.The current health status of the patient is unknown.
Event or Problem Description
It was reported that, after a navio assisted journey ii surgery was performed on (b)(6) 2021, the patient fell and a supracondylar fracture of the femur occurred at the navio bone pin 4.0mm x 127mm insertion point.A revision surgery was performed on (b)(6) 2021 to treat this adverse event.The fracture was treated with a plate.The current health status of the patient is unknown.
Additional Manufacturer Narrative
H3, h6: the navio bone pin 4.0mm x 127mm (japan), pfsd01008, used for treatment was not returned for evaluation, however two x-rays were provided for review.The two undated/unidentified photos of radiological images appear to be prior to the fracture as they do not clearly show a supracondylar fracture of the femur.Immediate post-tka images were not provided for comparison.A relationship between the reported event and the device was not established.A functional evaluation could not be performed because the device was not returned.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A capa, hhe/pra, field action review was not completed.The product was not returned and no evidence was made available to link the complaint to a capa, hhe/pra, field action.Based on the information provided, the root cause of the reported event could not be definitively concluded; however, the reported fall along with possible posterior femoral bone-pin perforation could not be ruled out as potential contributing factors to the reported event as immediate post-operative imaging was not provided for comparison.As with any surgical procedure, there is risk involved.Potential complications accompanying surgery may occur, including allergic reaction, infection, or serious injury.Surgical site nerve injury, vascular injuries of the lower extremity, soft tissue damage, minor bone gouging at the surgical site, or bone fracture, immature implant failure, unstable knee joint, limited or restricted knee range of motion, major or minor blunt impact injury, unintended laceration/puncture wound, minor burns, as well as osteonecrosis, could occur.Secondary surgical intervention to address complications associated with surgery or treatment may be necessary.The surgical technique and user manual address the use of bone pins for bicortical purchase and the user manual warns that ¿if the bone pin perforates the outside of the bone significantly, there is an increased risk of patient injury¿.This failure is an identified failure mode within the risk assessment and the anticipated risk level is still adequate.Per complaint details, a ¿revision¿ was performed 3 weeks post-implantation due to the patient ¿fell and a supracondylar fracture of the femur occurred at the navio bone pin insertion point.It was communicated that the fracture was treated with a plate and no further clinically relevant documentation was available for inclusion in the medical investigation.The patient impact beyond the reported fall, femoral fracture and subsequent plating/¿revision¿ could not be determined.The current patient status is unknown.No further medical assessment can be rendered at this time.Should additional clinical documentation become available in the future, the clinical/medical task may be re-evaluated.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO BONE PIN 4.0MM X 127MM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12561119
• Report Number: 3010266064-2021-00696
• Device Sequence Number: 13839800
• Product Code: OLO
• UDI-Device Identifier: 00885556628737
• UDI-Public: 00885556628737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: PFSD01008
• Device Catalogue Number: PFSD01008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB00043/NAVIO SURGICAL SYSTEM JAPAN
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 77 KG