MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO LONG ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR110006
Medical Device Problem Codes	Difficult to Insert (1316); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when they went to bur the femoral condyle during a navio assisted surgery, the first anspach drill wouldn't spin (the handpiece moved the drill forward but the drill wouldn't spin).They checked the surgeon was pressing the black pedal and were on "cut femur", unplugged the drill and tried again but the drill wouldn't work.When a second drill and long attachment, and the same burr were added into the first handpiece, they had not been put together properly, so they failed calibration.Upon removing the second drill from the first handpiece, the second long attachment got stuck in the first handpiece and couldn't be removed.Therefore, the surgeon was repeatedly hit with a mallet, breaking the first handpiece, and potentially damaging the second long attachment and second drill.They opened a second handpiece and continued using the previous drill 2 and long attachment 2, but the nurse found it difficult to insert the burr into long attachment (previously damaged with the surgeon's hammering), so the surgeon hammered it in.The handpiece then passed calibration and the surgeon started to use it to remove bone, but at some point, the burr detached from the second drill and wouldn't stay inside the drill even when assembled correctly (previously damaged with the surgeon's hammering).Finally, the surgery was completed satisfactorily using a third handpiece, drill, and long attachment with a significant delay.The patient was not harmed beyond the problem reported.After surgery, during testing, it was found that the burr wouldn't go into the first long attachment.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Results of investigation: the navio long attachment, pfsr110006, s/n (b)(6), used for treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.The distal tip of the long attachment is blunt.The most likely cause of the blunted distal tip of the long attachment is product mishandling.Refer to the navio surgical system instrument kit cleaning and sterilization guide for proper handling.Care and caution should be exercised during setup, use, decontamination, and sterilization.A functional evaluation was performed.A bur was inserted into the long attachment.There was no resistance and the bur was inserted with no issues.The reported problem was not confirmed.Contributing factors associated with bur insertion are possible long attachment bearing wear.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.

• Brand Name: NAVIO LONG ATTACHMENT
• 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: 13653875
• Report Number: 3010266064-2022-00158
• Device Sequence Number: 2519077
• Product Code: OLO
• UDI-Device Identifier: 00885556628607
• UDI-Public: 00885556628607
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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
• Operator of Device: Health Professional
• Device Model Number: PFSR110006
• Device Catalogue Number: PFSR110006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: PFSR101209, ANSPACH HAND PIECE - SNK09311277002; PFSR101209, ANSPACH HAND PIECE - SNK09311348901; PFSR110137, NAVIO HANDPIECE - (B)(6) ; ROB00049, NAVIO SURGICAL SYSTEM UK, (B)(6)
• Patient Sex: Unknown