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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES RI ROBOTIC DRILL ATTACHMENT; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10015
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2022
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: case (b)(4).
 
Event Description
It was reported that, during a cori assisted tka surgery, the surgeon was burring his tibial twin peg holes, he removed the real intelligence robotic drill guard without issue.When he went to put the guard back on, the suction attachment broke off outside the patient; therefore, no broken pieces fell inside the patient.The procedure was finished with a smith and nephew back up device without delay.The patient was not harmed beyond the reported problem.Additionally, when assembling the trays after the case and after cleaning, it was noticed that the white plastic inside the ri robotic drill attachment (the wiper) was broken.
 
Manufacturer Narrative
Internal complaint reference: case (b)(4).
 
Event Description
It was reported that, during a cori assisted tka surgery, the surgeon was burring his tibial twin peg holes, he removed the real intelligence robotic drill guard without issue.When he went to put the guard back on, the suction attachment broke off outside the patient; therefore, no broken pieces fell inside the patient.The procedure was finished with a smith and nephew back up device without delay.The patient was not harmed beyond the reported problem.Additionally, when assembling the trays after the case and after cleaning, it was noticed that the white plastic inside the ri robotic drill attachment (the wiper) was broken.
 
Manufacturer Narrative
H3, h6: the ri robotic drill attachment (us), rob10015, (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.The wiper is completely missing from the distal end of the drill attachment.A functional evaluation was not required as the reported problem was confirmed visually.The most likely cause of this event is product mishandling.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.A historical escalation review was completed.A review of prior escalation actions found no actions applicable to the scope of the reported complaint this case.Refer to the cori surgical system user¿s manual for proper handling.Care and caution should be exercised during the surgical site setup, surgery and tear down to protect the device from an unforeseen force, such as falling onto a hard surface or damage.Refer to cori cleaning and sterilization care for proper handling during the cleaning and decontamination process to not damage or remove wiper from the distal end of the drill attachment.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.
 
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Brand Name
RI ROBOTIC DRILL ATTACHMENT
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 Key13295254
MDR Text Key285761240
Report Number3010266064-2022-00044
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556757345
UDI-Public00885556757345
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/06/2022
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 Model NumberROB10015
Device Catalogue NumberROB10015
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/05/2022
Initial Date FDA Received01/19/2022
Supplement Dates Manufacturer Received04/05/2022
Supplement Dates FDA Received04/06/2022
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 Unknown
Patient Sequence Number1
Treatment
ROB20000-CORI ROBOTICS USA
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