MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES ANSPACH EMAX 2 PLUS HAND PIECE - ROHS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR101209

Device Problems Physical Resistance/Sticking (4012); Interrogation Problem (4017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).Initial reporter: postal code (b)(6).

Event Description

It was reported that, during femur milling step in a navio assisted surgery, the error e2 and e8 popped on the anspach console.Therefore, the procedure was completed with manual instrumentation.The patient outcome is unknown.After the case, when the drill was connected to the console, the error e8 popped immediately.On repeatedly testing the drill, the errors e2 and e8 popped intermittently.However, there are many times in which the test passes.

Manufacturer Narrative

Section h3, h6: the anspach emax 2 plus hand piece - rohs, part number pfsr101209, serial number (b)(6) intended for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.Refer to the navio surgical system user¿s manual, section assembling the hardware, assembling the handpiece for proper set up and handling.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with drill locking mechanism has locked up prohibiting bur rotation creating e2 error.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: ANSPACH EMAX 2 PLUS HAND PIECE - ROHS
• Type of Device: 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: 12736498
• MDR Text Key: 279535950
• Report Number: 3010266064-2021-00738
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR101209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 08/04/2022
• Supplement Dates FDA Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ROB00036-NAVIO SURGICAL SYSTEM (B)(6); ROB00036-NAVIO SURGICAL SYSTEM (B)(6)
• Patient Outcome(s): Required Intervention