MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES RI BONE PINS 4 MM X 152 MM QTY: 2; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10011

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/10/2022

Event Type  malfunction  

Event Description

It was reported that, during a cori assisted tka surgery, the ri bone pins 4 mm x 152 mm bent.The procedure was finished with a smith and nephew back up device without significant delays.The patient was not harmed.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

Section d10 was updated.Section h10: the ri bone pins 4 mm x 152 mm qty: 2, part number rob10011, used for treatment was not returned for evaluation.An image was provided.A relationship between the reported event and the device was established.The reported problem was confirmed with a visual inspection.The images provided confirmed the device is bent.A complaint history review for similar reported/confirmed complaints has identified prior events.While all products meet required manufacturing specifications prior to release a serial number, lot number, part revision or software version is required to link the device to a dhr or nc investigation.A historical review concluded that no prior escalation actions are applicable to the scope of the reported complaint.The most likely cause of this event is associated with product mishandling during insertion or removal.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.Internal complaint reference number: (b)(4) section h6 (impact code) was corrected.

• Brand Name: RI BONE PINS 4 MM X 152 MM QTY: 2
• 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: 14538345
• MDR Text Key: 292959807
• Report Number: 3010266064-2022-00403
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757307
• UDI-Public: 00885556757307
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K201022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ROB10011
• Device Catalogue Number: ROB10011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CORI ROBOTICS, SERIAL: (B)(6)