MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES STRIDE INSERT TRIAL SIZE C 10MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	PFSR101004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a case today we had an issue with trialling the polys.Surgeon slid in the trial poly and each time he did so, it seemed to rock back and forth anterior to posterior inside the tibial tray.This caused issues trialling our final rom, especially when he tried to bring the leg into full extension where the poly was pushed to the posterior each time.The surgeon kept playing with poly trials until they were able to properly assess the fit.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h3, h6: the device, used for treatment, was returned for prior evaluation but discarded.Visual and functional inspection of the returned devices revealed the poly trials were all the correct size and despite some wear and tear damage, fit as expected in known good tibial trays.No problem found with the returned material.Additional information received from the site indicated that the user pressed down the most anterior portion of the poly trial upon the posterior portion with rock superiorly due to the geometry of the poly.This can be an indication that the contact points are very anterior on the poly/tibia.There was no impact to the patient.There was no part/serial/lot number provided for dhr review so it could not be concluded if the device met the manufacturing specifications.A complaint history review identified similar events.The naviopfs¿ system for unicondylar knee replacement released at the time of the complaint provides detailed instructions for placement and removal of the poly trial.The user is instructed to follow the tibia first: implant planning and placement guidelines when going through this process.The poly insert trial is designed to engage with the tibial trial when placed in the patient's anatomy and prevents any catching from respective geometries.The user's manual provides detailed instructions for placing the poly trial.We were unable to confirm there was a relationship established between the reported event and the device.The reported event was likely due to a very anterior single contact point causing the poly trial to tilt upwards in the posterior area, resulting in the "rocking" motion that was described.

• Brand Name: STRIDE INSERT TRIAL SIZE C 10MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest; blvd ste 40; plymouth, mn
• MDR Report Key: 9983814
• Report Number: 3010266064-2020-00358
• Device Sequence Number: 2952741
• Product Code: HSX
• UDI-Device Identifier: 00885556627747
• UDI-Public: 00885556627747
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: PFSR101004
• Device Catalogue Number: PFSR101004
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/31/2016
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 08/11/2020
• 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
• Patient Age: 49 YR