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

Catalog Number PFSR101209

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during a preventive maintenance, it was found that the anspach drill was damaged.It is unspecified what the failure was.No patient was involved.No other complications were reported.The investigation found that the anspach drill had a recessed pin.

Manufacturer Narrative

H3, h6: the navio drill, part number 101209, s/n (b)(6), intended for use in treatment was returned for evaluation.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.The reported problem was visually confirmed.The exterior condition of the device showed scratches, dings, hose worn, fraying cable at connector cap.A functional evaluation was performed.The bur would not remain in place during the drill test.The most likely cause of this event is component failure.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
• MDR Report Key: 12407097
• MDR Text Key: 274537251
• Report Number: 3010266064-2021-00622
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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: 11/03/2020
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1