MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE FEMORAL INS/REM IMPACTOR HEAD

Catalog Number PFSR100931

Device Problem Crack (1135)

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

Event Date 05/06/2021

Event Type  Injury  

Event Description

It was reported that, upon impacting the femur in a navio-assisted ukr surgery, the stride femoral ins/rem impactor head cracked in half inside the patient.The procedure was completed with the same device (wrapped with coban) without significant delays.The patient was not harmed.

Manufacturer Narrative

H3, h6: the navio stride femoral ins/rem impactor head, p/n pfsr100931, used in treatment, was returned for evaluation.A relationship between the reported event and the device was established.The reported event was visually confirmed.The exterior condition shows minor wear (scratches, scuffs).The component is broke and miss part of it.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 has identified prior events.The most likely cause of this event was external forces and/or pressure apply to the pin.Care and caution should be exercised during the surgical site setup, surgery and tear down to protect the device from an unforeseen force, such as falling onto a hard surface or damage.Refer to the navio surgical system user¿s manual for proper handling.Components break / wear or spinning bur contacts inside of guard causing flaking / material dust.Per information stated in the complaint, the procedure was successfully completed without delay using the same device.No patient injury or other complications were reported.This failure is an identified failure mode within the risk assessment.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.Additional information: d8/d9 corrected data: d4.

• Brand Name: STRIDE FEMORAL INS/REM IMPACTOR HEAD
• Type of Device: STRIDE FEMORAL INS/REM IMPACTOR HEAD
• 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: 11872967
• MDR Text Key: 252331569
• Report Number: 3010266064-2021-00406
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556627334
• UDI-Public: 885556627334
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR100931
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention