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

Model Number	PFSR100998
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the poly trial was chipped.The device was still used with success.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used for treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.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.Factors that could have contributed to the reported event may be related to the misuse by the user while removing/inserting the trials or wear and tear from repeated use.

• Brand Name: STRIDE INSERT TRIAL SIZE B 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
• MDR Report Key: 9983812
• Report Number: 3010266064-2020-00360
• Device Sequence Number: 11308808
• Product Code: HSX
• UDI-Device Identifier: 00885556627686
• UDI-Public: 00885556627686
• 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): 07/29/2020

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: PFSR100998
• Device Catalogue Number: PFSR100998
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2016
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR