MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE TRACKER ARRAY; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	PFSR120010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that scrub tech over-tightened array to navio handpiece using t-wrench and broke one of the two attachment screws so that the screw head came off but the body remained in its hole.Was able to proceed with surgery because the array was still fastened tightly with the one other screw.No injury 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 delay was less than 30 minutes, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
Event or Problem Description
It was reported that scrub tech over-tightened array to navio handpiece using t-wrench and broke one of the two attachment screws so that the screw head came off but the body remained in its hole.Was able to proceed with surgery because the array was still fastened tightly with the one other screw.No injury involved.Delay of less than 30 minutes involved.
Additional Manufacturer Narrative
H10: additional information in d10, h2, h3.H11: corrected information in b5, d4, g5.Results of investigation: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found 38 similar reports and this issue will continue to be monitored.A relationship, if any, between the subject device and the reported event could not be determined.A factor that could have contributed to the reported issue is if the thumbscrew was over tightened, causing it to break.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO HANDPIECE TRACKER ARRAY
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 8875655
• Report Number: 3010266064-2019-00107
• Device Sequence Number: 11397218
• Product Code: OLO
• UDI-Device Identifier: 00885556628577
• UDI-Public: 00885556628577
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/12/2020

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: PFSR120010
• Device Catalogue Number: ORPFSR100026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 08/12/2019; 08/12/2019; 08/12/2020
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 08/26/2019; 04/24/2020; 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1