MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO TISSUE PROTECTOR; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR015001
Medical Device Problem Codes	Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a navio assisted tka surgery the anspach emax 2 plus hand piece - rohs separated from the burr twice case (b)(4) and the navio tissue protector was getting bound up with a pin and has damaged the internal cannula case(b)(4).The procedure was completed, with a delay of fewer than 30 minutes.It is unknown how the procedure was completed.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Section h3, h6: the navio tissue protector, pfsr015001 (part number 101420), lot tu55805 was returned for evaluation.A relationship between the bound bone screw and the tissue protector could not be established.The bone screw was not returned stuck to the tissue protector, therefore no further evaluation could be performed and the reported problem was not confirmed.Although the reported problem was not confirmed through a visual evaluation, contributing factors may have been associated with the surgeon's insertion and removal technique.The reported damage to the distal end of the cannulas was observed as being roughed up as a result of wear and tear associated with repeated bone screw insertion and removal.A relationship between the reported event (damage due to repeated use) and the device was established.The most likely cause of this event is wear and tear due to repeated use.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints concluded this was an isolated event.A historical escalation event review was performed for a prior version of the part.The review determined that prior escalation actions are applicable to a prior version of this part and not the scope of this complaint.The entire product was not returned and no evidence was made available to link the complaint to an escalation event.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, the failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.
Additional Manufacturer Narrative
D4, d9, h3, h6.

• Brand Name: NAVIO TISSUE PROTECTOR
• 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: 12044154
• Report Number: 3010266064-2021-00471
• Device Sequence Number: 4581740
• Product Code: OLO
• UDI-Device Identifier: 00885556649558
• UDI-Public: 00885556649558
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152574
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2022

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: PFSR015001
• Device Catalogue Number: PFSR015001
• Device Lot Number: TU55805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 06/04/2021; 12/07/2022
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 12/01/2022; 12/15/2022
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NAVIO SURGICAL SYSTEM US, SN (B)(6)
• Patient Sex: Unknown