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

Catalog Number PFSR100338

Device Problems Overheating of Device (1437); Noise, Audible (3273)

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

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

The anspach drill intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The evaluation followed pv0005 rev.B.The reported problem was confirmed.There was a loud whining noise coming from the drill and it was hot to the touch following the test.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 associated with the part with the failure modes ¿noise audible¿ and ¿noisy ¿ identified similar events.The most likely cause of the overheating is mechanical failure of the drill motor shaft.The drill is an oem part and cannot be further disassembled to determine a root cause.Based on the investigation, no further containment or corrective action is recommended or required at this time.Our reference number: (b)(4).

Event Description

It was reported that during testing of a navio newly replaced hand piece, the recon rep performing the testing heard a high pitch sound when performing a drill test.He then removed the long attachment from the anspach drill, and performed the test again, holding the pedal down for roughly 60 seconds.The high pitch sound occurred again, and the drill started smoking, but it was not overheating.There was no patient or case involved, this happened during preventative maintenance.The investigation found that the drill overheated.

• Brand Name: ANSPACH EMAX 2 PLUS HAND PIECE
• 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: 11340762
• MDR Text Key: 232367274
• Report Number: 3010266064-2021-00120
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR100338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2021
• 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: N
• Patient Sequence Number: 1