MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE PIN 4.0MM X 127MM; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSD01008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the surgery, during the washing of the instruments, it was found that the pin of the bone pin was broken.No case involved (there was no harm to patients).

• Brand Name: NAVIO BONE PIN 4.0MM X 127MM
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10015715
• Report Number: 3010266064-2020-01568
• Device Sequence Number: 14135291
• Product Code: OLO
• UDI-Device Identifier: 00885556628737
• UDI-Public: 00885556628737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: PFSD01008
• Device Catalogue Number: PFSD01008
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1