MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CHECKPOINT PINS QTY:4; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, once the cori-assisted tka surgery was finished, one real intelligence checkpoint pin broke in half when it was being pulled out.The remaining part was pulled out easily.There were no delays and the patient was not harmed.
Additional Manufacturer Narrative
The real intelligence checkpoint pin (b)(6), used for treatment was returned for evaluation.A relationship between the reported event and the device was established.The checkpoint pin is snapped off at the third barb from the bottom.A functional evaluation was not performed.The reported failure was confirmed visually.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints found 1 similar event.The most likely cause of this event is wear and tear associated with repeated insertion and removal eventually wearing away at the barb on the pin.A historical capa, nc, hhe/pra, field action review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.Refer to the product users manual for guidelines for proper removal of checkpoint pins and to always inspect for fragments and thoroughly irrigate the surgical site prior to closing the incision.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Per complaint details from (us) it was reported that, once the cori-assisted tka surgery was finished, one real intelligence checkpoint pin broke in half when it was being pulled out.The remaining part was pulled out easily.There were no delays and the patient was not harmed.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: REAL INTELLIGENCE CHECKPOINT PINS QTY:4
• Common Device Name: 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: 11988913
• Report Number: 3010266064-2021-00443
• Device Sequence Number: 4440133
• Product Code: OLO
• UDI-Device Identifier: 00885556757314
• UDI-Public: 00885556757314
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ROB10012
• Device Catalogue Number: ROB10012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 06/13/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown