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

Catalog Number PFSR101209

Device Problems Device Reprocessing Problem (1091); Interrogation Problem (4017)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that when they went to plug in the anspach drill to calibrate the handpiece during a navio tka procedure, they noticed water sitting on the inside of the cap and, when turned down, the water came running out of the prongs.Just to check, they plugged it in and immediately got an error.They swapped anspach handpieces and continued as normal without delay.No patient injury was reported.No other complications were reported.

Manufacturer Narrative

H6: the navio drill part number 101209, s/n (b)(6), used for treatment was not returned for evaluation thus, a visual and functional evaluation could not be performed and a relationship between the reported event and the device could not be determined.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 the reported problem was not confirmed a factor that may have contributed to the reported symptom may have been mishandling of the device, thus causing the water ingress and subsequently producing an e6 error.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.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

Manufacturer Narrative

H3, h6: the anspach emax 2 plus hand piece-rohs pfsr101209, s/n (b)(6) intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.There is a 1/2 inch slit in the hose 3 feet from the drill.The slit will allow water ingress during the decontamination/cleaning cycle and explains why water was present in the cap.A functional evaluation was performed.The reported problem was not confirmed.The reported e6 error did not present.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 found similar events.The most likely cause of this event (water in cap) is due to slit in hose and due to product mishandling.Perhaps error was e5 not e6 which would have been more consistent with reported problem.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.Refer to the product instructions for use.Care and caution should be exercised when handling cable and connectors during setup, takedown, decontamination and sterilization.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.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.Corrected data: d4 (serial number).

• 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: 11716284
• MDR Text Key: 248363584
• Report Number: 3010266064-2021-00297
• 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,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 08/27/2021; 04/25/2022
• Supplement Dates FDA Received: 08/29/2021; 04/27/2022
• 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: A
• Patient Sequence Number: 1
• Treatment: NAVIO SURGICAL SYSTEM US, SN (B)(6).