MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE FEMORAL INS/REM IMPACTOR HEAD; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	PFSR100931
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a navio assisted ukr surgery, the stride femoral ins/rem impactor head split in half while impacting.No delays were reported.The procedure was finished with a smith and nephew back up device without delays.The patient was not harmed.
Additional Manufacturer Narrative
The stride femoral ins/rem impactor head (us), product pfsr100931, used for 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 determined.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.Although the reported problem was not confirmed, a factor that may have contributed to the reported symptom may have been associated with natural wear and tear.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.This failure is an identified failure mode within the risk assessment.Per complaint details from the us it was reported that the stride femoral ins/rem impactor head split in half while impacting during a navio assisted ukr surgery.The procedure was finished with a smith + nephew back up device without delays.Clinical documentation/information was not provided for inclusion in the investigation.Based on the information provided, patient impact beyond the reported modified procedure would not be anticipated as no patient injury was alleged.No further assessment is warranted at this time.Should additional information/ documentation become available, the clinical/medical task may be opened for further evaluation.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 at a future date, this evaluation will be reopened for investigation.

• Brand Name: STRIDE FEMORAL INS/REM IMPACTOR HEAD
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 12342989
• Report Number: 3010266064-2021-00611
• Device Sequence Number: 17096741
• Product Code: HSX
• UDI-Device Identifier: 00885556627334
• UDI-Public: 885556627334
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PFSR100931
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 11/16/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown