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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES ANSPACH EMAX 2 PLUS HAND PIECE - ROHS ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number PFSR101209
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/14/2020
Event Type  malfunction  
Manufacturer Narrative
The anspach drill intended for treatment was returned for evaluation. The reported problem was confirmed. The hose was completely torn 30" from the drill end, revealing the underlying conductors. 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. The drill was running extremely hot to the touch. 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 ¿material split, cut or torn¿ and ¿damaged cord¿ identified similar events. The most likely cause of this event is 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. (case-(b)(4)).
 
Event Description
It was reported that during sterile processing, it was found that the cord of the anspach drill was torn and wiring was exposed. No patient was involved. No other complications were reported.
 
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Brand NameANSPACH EMAX 2 PLUS HAND PIECE - ROHS
Type of DeviceORTHOPEDIC 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
MDR Report Key11240467
MDR Text Key229114159
Report Number3010266064-2021-00059
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPFSR101209
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2021
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

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