MAUDE Adverse Event Report: EXACTECH, INC. TRU DISTAL FEM CUT BLOCK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	TRU DISTAL FEM CUT BLOCK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during surgical use, the pin became lodged in the cutting block and broke off in the pin remover as well.There was no breakage of a device.Patient required prolonged hospitalization as a direct result of this issue.The sales rep was unable to obtain photos/x-rays.The device is available for evaluation.
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
After further review of additional information received the following sections b5, d9, g3, g6, h2, h3 and h6 have been updated accordingly.B5: additional information received indicates that the pin got stuck in the block with delayed the surgery by 5 mins.No health consequence to patient.H3: based on historical complaint investigation and the returned devices, the jamming reported was likely the result applying a bending moment during insertion of the pin which resulted in contact between the pin and inner surface of the cutting block and led to galling.The fracture may have been the result of applying a bending moment to remove the pin from the cutting block after becoming jammed.The most probable root cause associated with the reported event of "broken - minor surgical delay¿ is associated with an undesired material change in shape or property caused by external forces and also associated with a partial or full-thickness crack in the device materials.

• Brand Name: TRU DISTAL FEM CUT BLOCK
• 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: 13772221
• Report Number: 1038671-2022-00261
• Device Sequence Number: 3822555
• Product Code: LXH
• UDI-Device Identifier: 10885862523006
• UDI-Public: 10885862523006
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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: TRU DISTAL FEM CUT BLOCK
• Device Catalogue Number: 02-029-11-8000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 04/18/2022
• 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
• Patient Sex: Unknown