MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO BONE SCREW DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR110164
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during tka surgery, the navio bone screw driver was broken.They had to remove the bone pins from the patient's bone using a jacobs chuck (competitor device).The procedure was completed, with a non-significant delay, using the competitor device.
Additional Manufacturer Narrative
Results of investigation: the navio bone screw driver pfsr110164, lot 8012627 (united kingdom) used for treatment was returned for evaluation.A relationship between the reported event and the device was established.The reported problem was visually confirmed.The driver has separated from the pin driver body.A functional evaluation was not required as the reported problem was confirmed visually.A review of manufacturing records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints found similar events.A historical escalation event review was completed.A review of prior escalation actions determined this case and lot number is associated with a previous corrective action.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.Hence, no further containment action is required.The most likely cause of this event is mechanical component failure and breakdown/defect of the weld.Further investigation into the reported failure has been conducted, and the potential root cause is a combination of durability issues after extended use (expected wear and tear rate), abnormal use of the tools, or inherent variations in the manual weld process that are present across production lots.The investigation was closed with appropriate risk justification and objective evidence that led to the potential root causes listed above.Based on the investigation, no additional containment or corrective actions are recommended at this time.

• Brand Name: NAVIO BONE SCREW DRIVER
• 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: 13052883
• Report Number: 3010266064-2021-00889
• Device Sequence Number: 11750222
• Product Code: OLO
• UDI-Device Identifier: 00885556628614
• UDI-Public: 00885556628614
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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: PFSR110164
• Device Catalogue Number: PFSR110164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 03/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NAVIO SURGICAL SYSTEM UK
• Patient Sex: Unknown