MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO HANDPIECE THUMBERSCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	PFSR100026
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that, during set up for a navio assisted surgery, the navio handpiece thumberscrew was fractured.The procedure was finished with a smith and nephew back up device without delay.Since incident occurred before procedure, patient was not involved.
Additional Manufacturer Narrative
H3, h6: the navio handpiece thumbscrew, part number pfsr100026 (japan), intended for use in treatment was not returned for evaluation; thus, a visual and functional evaluation could not be performed, and a relationship between the reported event and the device could not be established.A functional evaluation could not be performed because the device was not returned.While all products meet required manufacturing specifications prior to release a serial number or lot number is required to link the device to a dhr or nc investigation.A complaint history review for similar reported/confirmed complaints found similar events.Although the reported problem was not confirmed a factor that may have contributed to the reported symptom may have been associated with mechanical component failure/damage.A capa, nc, hhe/pra, field action review was not completed.The product was not returned and no evidence was made available to link the complaint to a capa, hhe/pra, field action.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.

• Brand Name: NAVIO HANDPIECE THUMBERSCREW
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 12839853
• Report Number: 3010266064-2021-00780
• Device Sequence Number: 14673270
• Product Code: HSB
• UDI-Device Identifier: 00885556648421
• UDI-Public: 00885556648421
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122170
• 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): 02/01/2022

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: PFSR100026
• Device Catalogue Number: PFSR100026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown