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 12/03/2020

Event Type  malfunction  

Event Description

It was reported that, during a navio preventive maintenance, the anspach drill overheated and has a tear in the tubing.No patient was involved.No other complications were reported.

Manufacturer Narrative

The anspach drill intended for use in treatment was returned for evaluation.The reported problem was visually confirmed.The jacket is torn 1/8"" from the end of the drill.Although the reported problem was visually confirmed, a functional evaluation was performed on the part beyond the reported complaint.The evaluation followed pv0005 rev.B.The evaluation failed.High pitched sound and grinding coming from the drill.Drill runs hot to the touch as well.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 ¿overheating of device | material split, cut or torn¿ and ¿damaged cord, overheating¿ identified similar events.The most likely cause of the tear in the outer sheath improper handling.Care and caution should be exercised during the surgical site setup and tear down to protect the device cable and from sharp objects or from situations that pin the cable between two objects.Do not use excessive force on the device strain reliefs during the decontamination process to minimize separating the cable from the strain relief.Refer to the navio surgical system user's manual and the navio surgical system instrument kit cleaning and sterilization guide for proper handling.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.

• 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: 11089854
• MDR Text Key: 224589331
• Report Number: 3010266064-2020-02133
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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: 12/21/2020
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1