MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE INSERT TRIAL SIZE C 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	PFSR101002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that item broke during surgery.There was a back-up device available and the procedure was completed with no delays.It is unknown if there was impact to the patient due to this issue.
Additional Manufacturer Narrative
The report was inadvertently submitted under manufacturer number 1020279, but the correct manufacturer number is 3010266064.
Additional Manufacturer Narrative
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 similar reports and this issue will continue to be monitored.The stride unicondylar knee system instructions for use released at the time of the complaint provides instructions for using the insert.Accordingly, product labeling has been ruled out as a cause of the complaint.This failure is captured in the navio risk profile.A clinical/medical investigation noted that, without the requested clinical/medical information, a thorough medical investigation could not be performed.However, per complaint details, there was a backup device used to complete the procedure without delay and no patient injury/impact was reported.Therefore, no further medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.A factor that could have contributed to this issue is wear on the device over time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: STRIDE INSERT TRIAL SIZE C 8MM
• 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
• MDR Report Key: 9986811
• Report Number: 1020279-2020-01344
• Device Sequence Number: 3699896
• Product Code: HSX
• UDI-Device Identifier: 00885556627723
• UDI-Public: 00885556627723
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K123380
• 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
• Report Date (Section B): 08/17/2020

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 Model Number: PFSR101002
• Device Catalogue Number: PFSR101002
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018; 08/11/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 04/28/2020; 08/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention