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

Model Number	ROB10011
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon opening the tray, it was found that one of the ri bone pins 4 mm x 152 mm qty: 2 had been damaged.The bone pin is deformed and has damaged threads.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
The ri bone pins 4 mm x 152 mm, qty: 2, part number rob10011, intended for use in 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.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 has concluded this was an isolated event.Although the reported problem was not confirmed a factor that may have contributed to the reported symptom may have been regular wear and tear.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.

• Brand Name: RI BONE PINS 4 MM X 152 MM QTY: 2
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 12096448
• Report Number: 3010266064-2021-00496
• Device Sequence Number: 4169266
• Product Code: OLO
• UDI-Device Identifier: 00885556757307
• UDI-Public: 00885556757307
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 10/13/2021

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
• Operator of Device: Health Professional
• Device Model Number: ROB10011
• Device Catalogue Number: ROB10011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1