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

Catalog Number	ROB10011
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem Description
It was reported that it was noticed that there have been an incident of 6 broken/bent ri bone pins 4 mm x 152 mm qty: 2.They are no longer useable in cori cases and must be replaced.These pins were collected over a span of a couple months and were noticed before and after cases as unusable.If the case was open and the pins were bent, they were swapped with undamaged pins.As no case was involved, there was not any patient involved.
Event or Problem Description
It was reported that it was noticed that there have been an incident of six (6) bent ri bone pins 4 mm x 152 mm qty: 2.They are no longer useable in cori cases and must be replaced.These pins were collected over a span of a couple months and were noticed before and after cases as unusable.If the case was open and the pins were bent, they were swapped with undamaged pins.As no case was involved, there was not any patient involved.
Additional Manufacturer Narrative
Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting.The new information states that the reported devices were bent instead of fractured.Event may result in a short procedural delay and/or require use of a backup device to continue procedure.This event is not likely to cause or contribute to a death or serious injury and is considered not reportable.

• 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
• 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: 18435958
• Report Number: 3010266064-2024-00003
• Device Sequence Number: 7033720
• Product Code: OLO
• UDI-Device Identifier: 00885556757307
• UDI-Public: 885556757307
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K201022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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 Catalogue Number: ROB10011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/10/2024
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB10024 / SERIAL NUMBER: (B)(6).
• Patient Sex: Unknown