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

Catalog Number PFSR101209

Device Problem Overheating of Device (1437)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

The anspach emax 2 plus hand piece - rohs, used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed: the reported problem "does not hold the long attachment securely" was not confirmed.The customer drill was able to properly engage with a long attachment without issue.In regards to the allegation of motor not working during a case, the failure was not experienced.The drill, however, was not operating smoothly during the case or during the drill test, and was running hotter-than-expected in both cases.It is probable that on the field, the motor was run to the point where it stopped functioning during the case.Therefore, the problem will be confirmed, with probable cause being motor component failure.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints has identified prior events.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.

Event Description

It was reported that upon bone removal during a navio assisted uka surgery, the anspach emax 2 plus hand piece - rohs would not spin.All connections and assembly were checked.The collar locking mechanism on the drill is loose and does not hold the long attachment securely.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed.The investigation found that the drill was hotter-than-expected during the drill test and the burring stage.

Manufacturer Narrative

H3, h6: the anspach emax 2 plus hand piece - rohs, part number pfsr101209, serial (b)(6) and used for treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported problem could not be visually confirmed.A functional evaluation was performed: the reported problem "does not hold the long attachment securely" was not confirmed.The customer drill was able to properly engage with a long attachment without issue.In regards to the allegation of motor not working during a case, the failure was not experienced.The drill, however, was not operating smoothly during the case or during the drill test, and was running hotter-than-expected in both cases.It is probable that the in the field, the motor was run to the point where it stopped functioning during the case.Therefore, the problem will be confirmed, with probable cause being motor component failure.A review of manufacturing and service 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 capa, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.This failure is an identified failure mode within the risk assessment.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: 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: 12846759
• MDR Text Key: 281740079
• Report Number: 3010266064-2021-00774
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR101209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: NPFS02000, NAVIO SURGICAL SYSTEM US, SN004116