MAUDE Adverse Event Report: EXACTECH, INC. TIBIAL INSERT TRIAL SZ 3 13 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	TIBIAL INSERT TRIAL SZ 3 13 MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately twelve years post left tka, the (b)(6) female patient's poly failed over time.During surgery, a piece of the trial broke off but was retrieved.There were no parts or pieces that fell into wound site.Implant was removed and replaced with 15mm implant, but was deemed too tight so it was removed and downsized to a 13mm ps poly implant.There was no surgical delay/prolongation.Patient deemed stable.Patient was last known to be in stable condition following the event.Provided images show the tibial insert has fractured.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2022-00530.
Additional Manufacturer Narrative
After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) the broken instrument reported was likely the result of impaction forces being applied to the groove during trialing and/or removal which led to the observed fracture.The most probable root cause associated with the reported event of "broken / non-functional¿ is associated with a partial or full-thickness crack in the device materials.This is one of two products involved with the reported event and the associated manufacturer report numbers are 1038671-2022-00529 and 1038671-2022-00530.

• Brand Name: TIBIAL INSERT TRIAL SZ 3 13 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 14342011
• Report Number: 1038671-2022-00529
• Device Sequence Number: 4990431
• Product Code: LXH
• UDI-Device Identifier: 10885862042248
• UDI-Public: 10885862042248
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: TIBIAL INSERT TRIAL SZ 3 13 MM
• Device Catalogue Number: 201-23-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: - PS TIBIAL INSERTS SZ 3, 9MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female