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

Model Number PFSR110164

Device Problem Solder Joint Fracture (2324)

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

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that after a navio assisted surgery, the navio bone screw driver broke.The procedure was successfully completed without any delay, as they did not longer need the device.

Manufacturer Narrative

H3, h6: the navio bone screw driver pfsr110164, lot 8016483 (japan) used for treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The weld is broken and insert is loose.The most likely cause of this event is a broken weld between the insert and pin driver body.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.The review determined that prior escalation actions are applicable to the scope of this complaint however no further escalation action is required.The failure mode and associated risk have been anticipated within the risk file and that the documented risk level is still adequate.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
• 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: 13983082
• MDR Text Key: 288589720
• Report Number: 3010266064-2022-00242
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556628614
• UDI-Public: 00885556628614
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

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
• Device Operator: Health Professional
• Device Model Number: PFSR110164
• Device Catalogue Number: PFSR110164
• Device Lot Number: 8016483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/28/2022
• Supplement Dates FDA Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: NAVIO SURGICAL SYSTEM JAPAN-(B)(4).