MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; LOGIC CC FEM BOX TRIAL SIZE 5 RIGHT

Catalog Number	02-011-06-0750
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.
Event or Problem Description
As reported, during a knee procedure, the surgeon noticed that a wire coil and capture screw disengaged from the cc modular femoral box trial prior to trial reduction of the knee.The screw and coil were located and removed from the field.Patient was last known to be in stable condition following the event.The surgeon was able to finish the case.The broken trial did not appear to have any impact on results and will be returned.
Additional Manufacturer Narrative
(h3) the evaluation of the of the reported event noted that revision was likely the result of damage to the retaining ring during reprocessing or a prior surgical use, which resulted in disassembly of both the retaining ring and attachment screw.However, this cannot be confirmed as the retaining ring and attachment screw subcomponents were not returned for evaluation.

• Brand Name: EXACTECH
• Common Device Name: LOGIC CC FEM BOX TRIAL SIZE 5 RIGHT
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10403408
• Report Number: 1038671-2020-00479
• Device Sequence Number: 3066053
• Product Code: LXH
• UDI-Device Identifier: 10885862284860
• UDI-Public: 10885862284860
• 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): 02/11/2021

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 02-011-06-0750
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 02/11/2021
• 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: Other